Buyer II

Solar Design Engineer

Director, Engineering Services

Manager, Operations

Regulatory Affairs Manager

Technical Sales

Test engineer

Sr Field Application Engineer

Lead business Partner Supply Chain - Enterprise Systems - AMEA

Site Investigation Lead, Quality Assurance

Responsibilities: <ul><li>Support migration of Indirect Procurement processes from other Global countries to Alabang and prepare Indirect Procurement related process documentation (process maps and work instructions)</li><li>Become a Subject Matter Expert for Indirect Procurement related topics</li><li>Handle and resolve escalated procurement processing issues</li><li>Answer and resolve suppliers, stakeholders and AP queries to ensure timely resolution</li><li>Maintain supplier master data information in relevant systems</li><li>Ensure proper processing of PR’s and PO’s</li><li>Perform compliance checks</li><li>Expedite POs</li><li>Answer tickets (Procurement Helpdesk)</li><li>Manage invoice pricing issues</li><li>Create, maintain Info Record &amp; source lists</li><li>Spot Buy / Requisition Based Sourcing</li><li>Execute all procurement activities in-scope</li><li>Prepare and process eRFQ’s</li><li>Smaller Contract (value/complexity) negotiation &amp; execution</li><li>Execution of Projects assigned by Commodity Management</li><li>Desk Research and Price Comparison</li><li>Supplier training on tools</li><li>End-user Trainings</li><li>Savings reporting</li><li>Maintain communication with suppliers, stakeholders and other Indirect Procurement members</li><li>Execute periodically PR/PO audit queries or upon request KPI’s measurements</li><li>Ensure compliance with applicable client policies</li><li>Contribute to continuous improvement initiatives within the function, ensuring that improvements are incorporated in the work routine</li><li>Support robust compliance environment with applicable policies, procedures and processes</li><li>Build relationship with key stakeholders including suppliers</li><li>Support local BU owners, Function representatives or other Procurement team members to solve issues in a timely manner,</li><li>Build strong relationship with key stakeholders,</li><li>Attend team meetings and trainings as required.</li></ul> Requirements: <ul><li>Good Experience in Indirect Procurement (5+ years)</li><li>Previous experience in shared service environment</li><li>Good of MS office; very good Excel and other relevant tools for the function</li><li>SAP PR2, S/4</li><li>Good communication skills</li><li>Very good English language skills in speech and writing + additional language on top of Filipino preferred (Chinese, Spanish, German, French, etc.)</li><li>Diversified Industrial Products/Manufacturing industry experience preferred</li><li>Good command of other languages is a very important asset</li><li>Experience in a procurement shared service center supporting multiple countries / business units</li><li>Experience working for a Manufacturing company preferred</li><li>Good understanding of end-to-end S2P processes and associated technology platforms</li><li>Excellent organizational and analytical skills, solid problem solving and detail oriented</li><li>Strong communication skills</li><li>Ability to work with deadlines</li><li>Ability to work in culturally diverse teams with many levels of personnel.</li></ul>

Responsibilities: <ul><li>Work with cross functional teams to transform VOC into internal specifications and design features, documented properly as Product Requirements Document.</li><li>Design and develop new products for renewable applications using metallic and polymeric material to meet customer requirements</li><li>Assess technical risk and compliance of project</li><li>Prototype sample development for feasibility studies</li><li>Product Data management of engineering bill of materials</li><li>Executing on cost optimization/reduction (VA/VE) opportunities for the business</li><li>Engineering communication with global team and localize global product teams in China</li><li>Preparing design verification test plans, Design C Process FMEAs, FEAs</li><li>Engineering sample preparation for design and process verification tests</li><li>Executing test plan within the lab, ensuring successful product testing and verification results</li><li>Perform failure mode analyses and improvements to optimize product</li><li>Recording results of design reviews, design decision meetings, and writing technical summaries</li><li>Assisting with product compliance and approvals for all new products and platforms</li><li>Work with FAI approvals, Process Capability Study, judging manufacturing deviations and make decisions on deviation acceptance</li></ul> Requirements: <ul><li>Must have a minimum of an Bachelors degree in a discipline of Engineering</li><li>More than 5 years design experience on connector, plug or terminal. Solar or battery energy storage relevant or power / utility design experience is plus,not must</li><li>Ability to develop connectors to meet critical global standards, such as ANSI, UL, IEEE, and IEC</li><li>Component material selection to optimize strength, electrical insulation, stability, and longevity, while meeting the product and standard requirements</li><li>Basic knowledge of product development processes in a stage-gate approach</li><li>A basic understanding of manufacturing processes, such as molding, stamping, plating, and assembly processes</li><li>Possesses high degree of initiative, technical competence, engineering process knowledge and strong communication skills</li><li>Fluent communication with own team, customers, internal business leaders and technology leaders in English (CET-4 or above)</li><li>LDFSS or DMAIC 6-sigma black or green belt an advantage</li><li>Familiarity of engineering software: Creo or Pro/E</li><li>Mastery of office software, such as Word, Excel, PPT, etc.</li></ul>

Role Description: <ul><li>The Director, Engineering Services leads engineers and maintenance staff to maintain the existing facilities and equipment while developing engineering solutions to operational issues or new processes.</li><li>This position implements capital projects, establishes engineering project objectives and technical criteria for evaluating project results and activities of project team while supporting the policies, goals and objectives of the Company.</li></ul> Responsibilities: Engineering Project Management and Qualification <ul><li>Member of Site Leadership Team</li><li>Develops, plans, coordinates and directs engineering aspects of projects of major scope and importance</li><li>Manages IQ, OQ, PQ program. ?	Manages external engineering services and recommends resources required to carry out projects or improvements</li><li>Routinely has direct contact with outside consultants, technical counterparts from key vendors</li></ul> Facilities and Equipment Maintenance&nbsp; <ul><li>Directs the maintenance staff for routine PM and unplanned repairs of facilities and production equipment.</li><li>Manages calibrations within the plant through in-house or contract services.</li><li>Supports Serialization within the plant.</li></ul> Cross Functional Coordination&nbsp; <ul><li>Supports safety, health, and environmental policies and procedures</li><li>Works with Environmental Health and Safety to ensure city, county, state, and federal regulations relating to the projects and process improvements are met at all times</li><li>Directs, and enforces the safety program for the engineering group and reviews safety records to uphold standards of maximum safety for all maintenance and calibration staff</li><li>Coordinates activities with manufacturing, packaging, logistics, research and development, technical services and IT Departments</li><li>Communicates directly with the operations departments to coordinate engineering activities</li><li>Communicates directly with QA and QC laboratory to ensure effective participation by engineering staff in the implementation of QA policies and procedures</li></ul> Plant/Process Improvement&nbsp; <ul><li>Communicates regularly with all engineers, both individually and as a group, to ensure good two-way communication concerning operational improvements and projects</li><li>Assists with planning and implementing plant improvements and expansions</li><li>Prepares reports, analyzes data, and makes recommendations for improving plant operations and solving manufacturing/packaging-related problems</li><li>Initiates and carries out projects that improve efficiency and/or reduce operating costs</li><li>Coordinates with maintenance and operations staff in reviewing the operation of plant equipment and systems to minimize unplanned downtime, anticipate solve problems in a timely manner, and to identify opportunities for improvement</li></ul> Supervisory Responsibilities&nbsp; <ul><li>Conducts employee performance reviews based on job descriptions to determine competency, knowledge, and contribution of the engineering staff</li><li>Ensures that all engineering staff are trained on the most updated version of the operating procedures</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor of Science in a related technical field plus progressive technical experience and demonstrated competence</li><li>10 years progressive management experience in pharmaceutical engineering, pharmaceutical operations, and operations management</li></ul> Knowledge In-depth knowledge of the pharmaceutical plant operations is an asset Skills &amp; Abilities <ul><li>Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates activities; Makes oneself available to staff; Provides regular performance feedback; Develops subordinates skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.</li><li>Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.</li><li>Analytical -Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.</li><li>Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.</li><li>Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyones efforts to succeed.</li><li>Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others ideas and tries new things.</li><li>Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.</li><li>Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.</li></ul> Physical Requirements <ul><li>Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds</li><li>Climb ladders and work in high, precarious places up to elevations of 75 feet</li><li>Regularly exposed to work near moving mechanical parts</li><li>Exposed to wet or humid conditions</li><li>Exposed to outdoor weather conditions</li><li>Regularly exposed to high noise environments</li><li>Exposed to extremely dusty environments</li><li>Exposed to chemicals used in the manufacturing process Engineering</li></ul>

Role Description:&nbsp; <ul><li>The purpose of this job is to oversee the production schedules in accordance with approved production instructions, standard operating procedures, while utilizing cGMP for the preparation of commercial product.</li><li>Monitor and document in a periodic performance review the performance of the production staff. Identify opportunities for process and equipment improvements.</li><li>Mentor staff and set goals and objectives for the production personnel.</li></ul> Responsibilities: <ul><li>Manufacturing Operations Management</li><li>Assure the accurate execution of cGMP/DEA documentation relative to manufacturing and packaging activities.</li><li>Assure the accurate manufacturing of bulk drug product for delivery to primary packaging without deviation.</li><li>Assure the accurate packaging of drug product in approved primary packaging components without deviation</li><li>Assure the accurate sampling of raw material and the packaging of samples for shipment as appropriate to contract testing laboratories.</li><li>Assure the accurate assessment of component inventory and reconciliation.</li><li>Assure staff training requirements are established and complete prior to the performance of process or procedure.</li><li>Assure the accurate performance of basic routine preventive maintenance of equipment and facility cleaning activities by operators.</li><li>Establish performance Goals and Objectives based on facility needs and High Corporate Standards.</li><li>Complete routine performance evaluations of staff, and recommend growth opportunities.</li><li>Assure adherence to established production schedules and monitor production performance as determined by the Plant Director.</li><li>Monitor the general safety of staff and assure safe work practices are followed by all site personnel.</li></ul> Requirements: Education &amp; Experience <ul><li>Undergraduate Degree in Pharmacy, Engineering, or equivalent in training and experience.</li><li>10 years’ experience in a pharmaceutical manufacturing environment.</li><li>Prior cGMP experience in a pharmaceutical production environment is necessary. 3-5 years’ previous supervisory experience required.</li><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li></ul> Knowledge&nbsp; <ul><li>Knowledge of workplace health and safety requirements for applicable hazardous substances.</li><li>Must be able to demonstrate a high degree of understanding in the cGMP practices.</li><li>Must be able to demonstrate a high degree of understanding in the controlled drug substance regulations.</li><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li></ul> Skills &amp; Abilities <ul><li>Demonstrate knowledge of the current good manufacturing practices.</li><li>Ability to convey information clearly and concisely to both individuals and groups.</li><li>Ability to troubleshoot manufacturing processes, write investigations and complete documentation.</li><li>Ensure adequate staffing and efficient workflow and provide reports and data on manufacturing activity.</li></ul> Physical Requirements	 <ul><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary. Able to walk the production floor.</li><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary.</li><li>Able to walk the production floor.</li></ul>

Responsibilities: <ul><li>Ensure all products comply with applicable laws, regulations, and standards as per Indian laws</li><li>Stay updated on regulatory changes and assess their impact on the companys products or processes.</li><li>Either prepare or coordinate with originator, review, and submit regulatory documents such as dossiers, technical files, and applications for product approval or licensing.</li><li>To do necessary follow-ups with regulatory agencies to get approval of the medical devices / pharmaceutical products.</li><li>Work with Originator, and marketing teams to ensure product alignment with regulatory requirements.</li><li>Lead or assist in regulatory audits conducted by agencies or certification bodies.</li><li>Identify and mitigate regulatory risks that could impact product approvals or market access.</li><li>Develop and implement regulatory strategies to accelerate market entry and ensure sustained compliance.</li><li>Conduct training sessions for cross-functional teams on regulatory requirements and best practices.</li></ul> Requirements: Skills and Qualifications: <ul><li>Bachelors degree in Life Sciences, Pharmacy, Chemistry, Biomedical Engineering.</li><li>Advanced degree (e.g., MBA, MS, or Ph.D.) is an advantage</li><li>Strong knowledge of regulatory requirements (CDSCO, FDA, EMA, MHRA, TGA, etc.) and global standards (ISO, ICH, etc.)</li><li>Excellent project management and organizational skills</li><li>Ability to analyze and interpret complex regulations</li><li>Proficient in regulatory writing and submission tools</li><li>Strong communication and interpersonal skills</li><li>Ability to manage multiple projects and meet deadlines.</li></ul> Experience : <ul><li>7-10 years of experience in regulatory affairs, with a proven track record of successful submissions and approvals</li><li>Experience in handling registration of Medical Devices and getting approval.</li></ul>

Responsibilities: <ul><li>Delivers an extraordinary customer experience by technically advising customers on products, services, and capabilities to best meet the needs of the customer and the designs they are working on. Sells the value propositions of products and services.</li><li>Outbound calling (cold and warm) to establish new, high-quality opportunities with prospective customers and contacts.&nbsp;</li><li>Communicate with end customers via channels such as telephone &amp; email by following up on Marketing Qualified Leads (MQL’s) and propose options and solutions.</li><li>Liaison with internal support areas including production, sales, engineering, customer care and others as necessary to resolve customer inquiries and requests.&nbsp;</li><li>Conversations with the customers are geared towards understanding the customer’s needs through relevant probing questions and by extending conversations around project/opportunities.</li><li>A warm handoff of opportunities along with all required details to account managers for further nurturing.</li><li>Promote portfolio of products to drive revenue.&nbsp;</li></ul> Requirements: Education: <ul><li>Bachelors technical or business degree preferred or equivalent experience</li></ul> Skills &amp; Experience: <ul><li>Demonstrates problem solving skills, influencing abilities, and ability to provide effective feedback</li><li>Strong verbal, written, and presentation skills</li><li>Proven ability to initiate, organize, and complete multiple tasks in a timely manner</li><li>Demonstrates ability to share creative and new ideas</li><li>Consultative selling experience desired</li><li>Relevant product or industry experience a plus</li><li>·Team player, critical thinker, self-motivator, and ability to maintain a proactive positive attitude.</li><li>A passion for serving customers.</li><li>Mandarin speaking, writing and typing is required.</li><li>One to two years working experience is preferred, fresh graduates are welcome for the application as well.&nbsp;</li></ul>

Responsibilities: <ul><li>Be familiar with ASTM/ISO test standards and internal specifications, develop corresponding operation procedures.</li><li>Carry out qualification tests according to specification/SOP, ensure test tasks can be finished within schedule.</li><li>Support PM to test competitor products and customer’s application test.</li><li>Learn to operate flame test chamber and master flammability test method per UL224 all tubing and VW-1.</li><li>Support to do verification test for NPD projects</li><li>Develop new and improve existing test capability based on product test requirement.</li><li>Carefully record test data and results, check and review test data to meet specification requirements.</li><li>Analyze root cause of test failure and propose corrective action.</li><li>Prepare relevant test reports.</li><li>Take part in document management training, then upload test reports into PDMlink for approval.</li><li>Be responsible for maintenance of test equipment and instruments, spot check equipment carefully.</li><li>Maintain equipment calibration list and perform regular outsourcing calibration before expiration.</li><li>Purchase expendable chemicals, spare parts and tools in time, ensure they are available in any time.</li><li>Implement 5S and personal protection per company’s policy, ensure tidy environment and safety in lab.</li><li>Train and qualify new technicians.</li><li>Other job assigned by lab supervisor.</li><li>Continuous improvement. Look for and suggest efficiency improvements within qualification laboratory.</li></ul> Requirements: <ul><li>College or bachelor degree with more than 2 years working experience, major in material science is preferred.</li><li>Proficient in listening, speaking, reading and writing with Mandarin and English.</li><li>Be good at thinking and strong practical ability.</li><li>Good communication and interpersonal skills.</li><li>Familiar with PC and office software.</li><li>Hard-working and studious.</li><li>Be careful and responsible.</li><li>Team-work spirit.</li><li>Able to manage multiple priorities.</li><li>Stress resistant.</li><li>Flexibility to travel to suppliers, customers, company location. In-line with local travel protocols.</li><li>Have knowledge of VW/BMW/Daimler OEM specification advantage, but not essential;</li><li>Compounding or extrusion advantage, but not essential.</li></ul>

Responsibilities: <ul><li>Teamwork with account manager to design win company product in customer system</li><li>Work directly with customer to resolve technical issues including Server, Storage, Networking, IPC&nbsp;and computer peripherals product</li><li>Track, respond and manage customers technical inquiries</li><li>Make communication between customer engineer and internal engineering team</li><li>Technical Seminar/Product promotion &amp; training for customers</li><li>Create new concept and proposal for customers</li><li>Develop and maintain professional relationship with customers</li></ul> Requirements: <ul><li>Experience with one of following criterion:</li><li>FAE experience at least 3 years</li><li>Connector design experience at least 3 years</li><li>Server, Storage, Networking product design experience at least 3 years</li><li>2D/3D CAD skill is required.</li><li>Ability to speak a technical and a business language.</li><li>Strong problem solving and communication skills.</li><li>Willingness to travel and work in a global team of professionals.</li><li>Fluent English skill for both writing and speaking.</li></ul>

Responsibilities: <ul><li>Establishes and maintains a strategic relationship with key stakeholders in business and the IT organization.</li><li>Define and Drive Digital Supply Chain Agenda across process, people and technology collaborating with business stakeholders.</li><li>Provide thought leadership around the use of technology to achieve business goals and objectives.</li><li>Pioneer the development of a 3-5-year roadmap, providing annual reviews of status collaborating with business stakeholders and enterprise architects.</li><li>Supports development of the AMEA template across technology for these processes. Works with Global teams to establish the Global templates and ensure the sanctity of the templates.</li><li>Works with Functional Leads in other areas to discuss potential solutions that match the business strategy with the technology strategy.</li><li>Define solutions and execute optimal project plans with partner teams.</li><li>Proponent of Agile driving quicker and faster delivery with excellence.</li><li>Drive S4 HANA Template design and delivery for Supply Chain and Procurement modules.</li><li>Identify technology opportunities which provide strategic/tactical advantages in planning, managing and conducting the business.</li><li>Engage with key customers and other external business partners to deliver IT solutions in a high quality, globally conscious manner</li><li>Deliver innovative, efficient and cost-effective solutions to meet enterprise needs and to drive business growth and profitability.</li><li>Act as Leading change agent in delivering and embrace digital strategies. Influence the prioritization of Information Technology decisions for global businesses to ensure world-class delivery and value for IT investment.</li><li>Application Delivery – Define, analyze, and deliver business initiatives in accordance with business and IT priorities and annual budgets.</li><li>Build Talent – Promote and build global leaders, develop staff with the needed functional and technical skills required to meet organizations growing application portfolio and changing technology needs.</li><li>Provides Business Technology thought leadership, bringing knowledge and solutions to drive business outcomes.</li><li>Thinks ‘digital’ and embraces next generation ways of doing work.</li></ul> Advocacy&nbsp; <ul><li>Partner with Senior Business stakeholders to deliver business needs.</li><li>Manage 3rd party vendors ensuring high service level and optimal cost.</li><li>Ensure scalability of the programs by setting up the right framework.</li><li>Invest in building talent and develop high performing teams.</li><li>Supports service improvement and business-as-usual projects by working with various service owners and Architects.</li><li>Negotiate agreements and commitments by facilitating communication between business stakeholders and IT from initial requirements to final implementation.</li><li>Champions change management activities to minimize disruption and achieve desired results from initiatives that are enabled by technology.</li><li>Work with service managers / Vendor teams on key BU business issues, identifying and resolving potential problems and conflicts.</li><li>Collaborate with other IT functional areas to remain apprised of project status and inform stakeholders of progress.</li><li>Work with program delivery and excellence guidelines and ensure that every project is following the same.</li></ul> Consulting <ul><li>Contributes to the business’ strategic planning process.</li><li>Provides strategic technology and process consultation to business.</li><li>Performs assessments and provides recommendations on IT and business initiatives and solutions based on business relevance.</li><li>May advise on options, risks, costs versus benefits, and impacts on products, business processes, and system priorities.</li><li>Analyzes and advises on new business initiatives.&nbsp;</li><li>Stays abreast of industry trends in business and technology to determine impact to the achievement of organization(s) goals.</li><li>May recommend options, identifies risks and analyzes cost vs. benefits.&nbsp;</li><li>Provides strategic consultation to stakeholders in defining or designing business processes, functions and organizational structures.</li></ul> Business Case&nbsp; <ul><li>Works with business teams to understand project requirements, shapes the initial project request, and provides a high-level estimate of the project effort and cost used in cost-benefit analysis&nbsp;</li><li>Conducts feasibility studies and makes recommendations to stakeholders based on its alignment with the business strategy and roadmap.&nbsp;</li><li>Contributes context to the business case such as recommending expenditures based on the size, scope, and cost of hardware and software components.&nbsp;</li><li>Ensures anticipated benefits are realized and key process indicators and report card is measured, tracked and communicated.</li></ul> Planning and Prioritization&nbsp; <ul><li>Works with organization stakeholders and technical resources to create and implement a solution required to meet organization(s) business goals.</li><li>Monitors business demand to enable appropriate planning of IT’s resources.</li><li>Maintains awareness of changes to organization(s) strategy, goals and processes to ensure solutions/requirements/priorities appropriately reflect the needs of the organization(s)&nbsp;</li><li>Facilitates changes when necessary.</li></ul> Risk Management <ul><li>Works with business stakeholders in the identification and evaluation of risks associated with business decisions.</li><li>Identifies risks, outside of current project scope, that will impact the organization(s) such as business process or IT security.</li><li>May help in the development of risk mitigation plans.</li></ul> Communications <ul><li>Business Partnering to collaborate and manage business expectations.</li><li>Stays informed on project(s) status to provide business with regular status.</li><li>Communicate with organization’s stakeholders, project managers, and other to ensure awareness of progress, risks, and results.</li></ul> Measurements <ul><li>Ensures that projects align with the technology that best provides maximum return on investment.</li><li>Works with business and IT executives to define business and IT performance metrics.</li><li>Measures, tracks and reports on benefits realization, IT performance, and customer satisfaction levels.</li></ul> Service Level Agreements (SLAs) <ul><li>Reviews Service-Level Agreements (SLAs) with clients in accordance with IT standards and specifications as required</li><li>Communicates SLA results and issues to appropriate stakeholders</li><li>Work is performed in a Hybrid environment including normal work activities.</li><li>Role is located in India - Bangalore</li><li>Travel to international/domestic locations based on project asks</li></ul> Requirements:&nbsp; <ul><li>13-16 years of relevant functional and technical work experience.</li><li>Engineer / MBA or equivalent degree in Tech/ Information Systems from tier 1 college.</li><li>Extensive experience as IT Business partner for Supply Chain Function, with functional knowledge across all verticals within supply chain.</li><li>Proven experience in both Make and Non-Make domain through delivery of IT Initiatives for Plan, Source, Make, Deliver verticals.</li><li>Good Knowledge of SAP ECC and SAP S4, with functional expertise in SAP Supply Chain modules such as MM, PM, WM, QM, PP.</li><li>Should have managed multiple vendors to deliver complex IT Projects.</li><li>Should have led large scale Supply Chain tech transformation programs.</li><li>Has the experience and cultural awareness required to work effectively with a global team</li><li>Developing strategic plans and setting timelines for evaluation, development, and deployment of solutions</li><li>Identifying opportunities for simplifications and digitization of various workflows across the organization</li><li>Supervising quality assurance processes, integration, and system tests</li><li>Excellent leadership, team building, and management skills</li><li>Ability to Communicate and inspire confidence at a senior level with technical and non-technical audiences</li><li>Experience in identification, evaluation and documentation of process flows, risks and controls</li><li>Ability to engage with functional business leaders at a strategic level, as well as with delivery teams at an operational level</li><li>Hands-on experience leading such areas end-to-end and track record of delivering results and business value</li><li>Requires team leadership skills, experience/in-depth knowledge of business operations and IT processes</li><li>Experience with organizational change management preferred</li><li class="ql-align-justify">Proficient in English Language (Writing, reading &amp; Speaking)</li></ul>

Responsibilities: Investigation Management <ul><li>Timely review and support to closing of OOS/OOT/Deviations/Market complaints/Customer notifications as an investigational SME Role.</li><li>Review and ensure identified Root cause/Hypothesis is based on sound scientific Rationale and evidence.</li><li>Review and ensure Investigation order is proper and logical.</li><li>Review and ensure Investigation articulation is proper and not Misleading /Ambiguous.</li><li>Review and ensure Identification of CAPA’s is consistent with investigation findings</li><li>Provide appropriate rating to Root cause investigation based on Hypothesis, Investigation order, Investigation articulation and Identification of CAPA’s.</li><li>Undertake continuous trainings and developments from an outcome of Investigations and CAPA’s.</li><li>Implementation of best practices in Investigation review mechanism, policies, processes and procedures to aid and improve operational performance and Quality Metrics.</li><li>Support to Implement all relevant procedures described in the Quality Management System (QMS) like Deviation, RCI, Complaint management etc.,</li><li>Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.</li><li>Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy.</li><li>Review and identify areas of improvement in the investigations.</li><li>Ensure the compliance with current industrial practices and constantly meet the regulatory requirement with zero integrity issue.</li></ul> Workload Management&nbsp; <ul><li>Coordinate workload sharing with Investigators team and develop action plans to improve timeline and quality of investigations</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li></ul> Staff Development	 <ul><li>Evaluate potential candidates for Investigation team, performance evaluation of direct reports.</li></ul> Requirements: Education &amp; Experience&nbsp; <ul><li>Bachelor’s degree in pharmacy, Chemistry, Biotechnology, or related scientific discipline (master’s preferred)</li><li>10+ years of experience in pharmaceutical manufacturing, quality, or compliance roles, including investigation management</li><li>Prior experience leading teams and conducting root cause analysis for deviations, OOS/OOT, and quality events</li><li>Working knowledge of FDA, EU, and other global regulatory requirements Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>In-depth understanding of cGMP regulations, 21 CFR Part 211, ICH Q9/Q10 principles</li><li>Strong knowledge of manufacturing and QC processes for solid oral dosage forms, non-sterile liquids and semi-solid dosage forms</li><li>Familiarity with investigation tools and techniques (e.g., 5 Whys, Fishbone, FMEA)</li><li>Experience with Quality Management Systems (e.g., TrackWise, MasterControl)</li><li>Skills &amp; Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li><li>Excellent analytical thinking and problem-solving skills</li><li>Excellent critical thinking and root cause analysis skills</li><li>Ability to work cross-functionally and influence without authority</li><li>Proven ability to meet deadlines while handling multiple investigations</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Ability to work on-site full-time in both office and GMP environments</li><li>Sit or stand for extended periods; walk between manufacturing and laboratory areas</li><li>Ability to occasionally lift or move materials up to 25 pounds</li><li>Use of personal protective equipment (PPE) as required Investigation Management</li></ul>

Skills

Industry

Location

Jobtitle

28 writing Jobs found

Buyer II

Solar Design Engineer

Director, Engineering Services

Manager, Operations

Regulatory Affairs Manager

Technical Sales

Test engineer

Sr Field Application Engineer

Lead business Partner Supply Chain - Enterprise Systems - AMEA

Site Investigation Lead, Quality Assurance

WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

28 writing Jobs found

Buyer II

Solar Design Engineer

Director, Engineering Services

Manager, Operations

Regulatory Affairs Manager

Technical Sales

Test engineer

Sr Field Application Engineer

Lead business Partner Supply Chain - Enterprise Systems - AMEA

Site Investigation Lead, Quality Assurance

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.