Manager, Operations

Senior Quality Specialist

Sr Quality & Reliability Engineer

Manufacturing & Process Development Engineer II (Wire & Cable)

Assistant Manager, Continuous Improvement

Sr. MFG & Process DVL Engineer

Quality Engineering Supervisor

Line Manager (Improvement)

Facilities & Utilities Manager

Site Investigation Lead, Quality Assurance

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>Point of Contact for all quality matters, enquiries, and support to both internal and external customers</li><li>Develop, implement and align quality strategies to ensure processes and procedures meet quality excellence standards</li><li>Lead and mentor colleagues at sales operations offices, fostering a culture of excellence and accountability</li><li>Oversee the management of ISO 9001:2015 and quality system (CAPA, Change Management, Investigation, etc.)&nbsp;</li><li>Manage, own and investigate product complaints</li><li>Business Process Owner for Document Control</li><li>Analyse and track quality metrics such as Complaint KPI</li><li>Conduct/Host audits (internal and external) and inspections to ensure compliance with regulatory, quality and internal standards</li><li>Manage and negotiate quality agreements with end customers, group legal and global quality&nbsp;</li><li>Support quality documentation requests from customers</li><li>Ensure documentation and traceability of quality processes and corrective actions</li><li>Facilitate quality management reviews and relevant quality meetings</li><li>Manage supplier quality and conduct vendor assessments when necessary</li><li>Collaborate with cross-functional teams (e.g., global supply, sales, global quality, support teams) to resolve quality issues</li><li>Stay updated on industry trends, standards, and regulatory changes (where required)</li><li>Drive continuous improvement initiatives using Lean, Six Sigma, or other methodologies</li></ul> Requirements:﻿ <ul><li>Bachelor’s degree in Biological Sciences, Quality Engineering, or related fields</li><li>5+ years of experience in quality assurance, quality compliance, supplier quality or quality operations&nbsp;</li><li>Strong knowledge of QA methodologies, tools, and standards (e.g., ISO 9001:2015, ISO 13485, cGMP/GxP relevant)</li><li>Auditor certification in quality standards preferred</li><li>Strong knowledge in investigation and RCA methodology, and technical writing skills</li><li>Proficiency in quality management systems softwares (e.g., Trackwise)</li><li>Excellent analytical, problem-solving, and decision-making skills</li><li>Strong communication and interpersonal skills</li><li>Able to work in fast-paced, dynamic environments</li><li>Detail-oriented with a strategic mindset</li><li>Independent, Proactive and Task-driven</li><li>Leadership experience preferred</li></ul>

Responsibilities: olicies And Procedures, Quality System: <ul><li>Implement quality policies, procedures and systems; maintain/update quality engineering work instruction in order to ensure the business procedures in line with QS and global standards.</li><li>Involve in customer audit, implement responsible procedures and facilitate other departments to close their actions on time and fulfil requirement to our products and process in order to meet customer requirement and our quality system"</li></ul> Incoming Materials Quality Issue Handling: <ul><li>Analyze and identify material issues found in production line, drive SQE for supplier improvement in order to maintain incoming material quality."&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li></ul> Process Quality Issues Handling: <ul><li>Handle quality issues occurred in process in order to improve and maintain product quality performance, perform risk assessment to take proper disposition, develop improvement action to prevent the occurrence.</li><li>Drive improvement for nonconformance detected by QC.</li><li>Lead team to develop error-proof and mistake proof solution for quality risk identified. In order to achieve good quality performance of product.</li></ul> Customer Complaints/Feedback Handling: <ul><li>Handle customers complaints including develop and implement customer complaints corrective and preventive action plan in order to maintain the relationship with customers and provide extraordinary customer experience to customer.</li></ul> Quality documents and criteria setting: <ul><li>Develop quality engineering documents (QIP,WI,VA), set up and develop quality inspection criteria, prepare COC format in order to maintain product quality performance.</li></ul> Quality Improvement: <ul><li>Develop and track assigned process quality improvement plan according to product quality performance and implement situation in order to improve and maintain product quality performance. Using the DMAIC method to drive the improvement.</li><li>Work with team to qualify the process change/new line qualification/new machine, foresee quality risk and advise robust tooling/process design, identify the risk/gap and drive proper improvement action, follow up until action closed in order to improve and maintain product quality performance.</li></ul> Scrap control and improvement: <ul><li>Review and approve WIP scrap application</li><li>Monitor WIP scrap and take proper countermeasures</li><li>Follow up top failures in process, identify root cause and major contributor, drive team to take solid improvement action to improve</li><li>Validate the improvement action and follow up the result</li><li>in order to maintain product quality performance&nbsp;</li></ul> Requirements: Education, Technical Qualification &amp; Experience: <ul><li>College diploma major in engineering</li><li>3 years electronics industry quality related working experience, 1 year SMT experience is preferred.</li><li>Green belt/Black belt certification is preferred, can lead the team to do the DOE/GR&amp;R and data analysis ability.</li><li>Familiar with manufacturing process of cable assembly, such as terminal and IDC crimping, soldering, electrical testing, signal integrity etc.</li><li>Familiar with electrical industry specification such as IPC620, IPC610 etc.&nbsp;&nbsp;</li></ul>

Responsibilities:&nbsp; <ul><li>Lead process development, implementation, and documentation for bulk cable manufacturing.</li><li>Support product/process validation and transfer activities.</li><li>Assist with product qualification, working closely with engineering and test lab teams.</li><li>Partner with Product Development/Design Engineering to ensure manufacturability.</li><li>Interact with test laboratories on process/product qualification tasks, including DOE, PFMEA, 8D investigations, and Failure Analysis (FA).</li><li>Support tooling specification and design for manufacturing processes.</li><li>Provide engineering support to additional manufacturing sites as required.</li><li>Collaborate with suppliers to ensure process compliance and capability.</li><li>Support SAFE (Safety Activities For Employees) and ISO quality compliance initiatives.</li><li>Provide technical support for manufacturing maintenance activities.</li><li>Participate in cross-functional projects that support business growth and continuous improvement.</li></ul> Requirements:&nbsp; <ul><li>Strong knowledge of materials, processes, and systems used in wire and cable manufacturing.</li><li>Proficient in CAD software for tooling and process design.</li><li>Practical knowledge and experience with SPC (Statistical Process Control), Six Sigma, and Lean Manufacturing principles.</li><li>Ability to manage multiple projects and deliver results under tight timelines.</li><li>Willingness to travel internationally up to 30% as required.</li></ul>

Responsibilities: <ul><li>Strong knowledge with Continuous improvement tools and employs Lean methodology to support the annual Strategy Development&nbsp;</li><li>Ability to engage teams and upper management- be a face of the company at each department.</li><li>Experienced with Leader Standard Work behaviour activities.&nbsp;</li><li>Ability to handle a variety of tasks to work with plant leaders and the facility manufacturing team to execute existing processes.</li><li>Conducts regular assessments against the KWS phase progression criteria with the CIPO Team, identifies gaps, and puts actions in place to close the gaps.</li><li>Train, coach, and mentor others on enhanced processes on continual basis on CI and KWS tools and methodologies.&nbsp;&nbsp;</li><li>Acquires knowledge of KWS, lean manufacturing and industry “best in class” manufacturing operations practices to serve as a subject matter specialist.</li><li>Supports the Plant KWS team which consist of Center Of Excellence CIPO (members)</li><li>Supports the appropriate Center Teams based on Plant needs and KWS Phase progression.</li><li>Regular audits &amp; analysis to:&nbsp;&nbsp;</li><li>Identify and recognise areas of KWS compliance.&nbsp;</li><li>Identify, recognise and support implementation of KWS “best practices”</li><li>Identify areas of opportunity &amp; work with plant team to correct.</li><li>Works with other plants to share and implement KWS “best practices”</li><li>Support ongoing cross-functional teams savings opportunities analyses, tracking and updates.</li><li>Supports Technician Training in support of Technician Progression</li><li>In absence of Plant CI&amp; KWS Senior Manager, responsible for Site Daily Meeting Cadence with Tier 1-4 meetings and provides monthly analysis on the health and results sustainability.</li><li>Supports the Plant Smart Factory implementation.</li><li>To guard standards and regulations on EHS, QFS and other fundamentals by participating in and coaching during Leader Led Observations, Safety 7, Golden 6, and other EHS and QFS activities. Provide support and involvement in all internal and external audits.&nbsp;</li></ul> Requirements: <ul><li>Bachelor’s degree in a related field and&nbsp;</li><li>Minimum 5 years of experience in a manufacturing environment, with exposure to CI, Lean, or Six Sigma.</li><li>Able to work effectively in a fast-paced high-pressure environment</li><li>Understands and meets internal and external business needs with professionalism and a sense of urgency.&nbsp;</li><li>Experience in project management and cross-functional collaboration.</li><li>Able to balance conflicting priorities and still provide the organisation with clear direction and focus.&nbsp;</li></ul>

Responsibilities: <ul><li>Participates in the Design and Development of tools and molding processes to support the development of new products.</li><li>Provides support in product development, manufacturing optimization designs, tooling sampling, product samples, and prototypes.</li><li>Determines the most suitable manufacturing concepts for tooling related to forecasted production quantities, quality requirements, and manufacturing location</li><li>Responsible for collaborating with global experts (CoE molding) to continuously update and improve operational standards regarding plastic injection molding</li><li>Responsible for providing budgets for new tools and molding processes.</li><li>Responsible for ensuring, together with the multidisciplinary team, that molds and processes are designed to produce high-quality products efficiently and effectively with the lowest possible cost.</li><li>Responsible for coordinating and tracking engineering changes to injection molds.</li><li>Responsible for supporting the management of resources for the mold shop area.</li><li>Responsible for participating in the Plants Continuous Improvement Programs.</li><li>Provides support in analyzing tooling and equipment capacities for new part numbers and changes in quoted volumes.</li><li>Responsible for participating in the development of new products, engineering changes for molds, ensuring adherence to engineering and internal standards.</li></ul> Requirements: Preferred Years of Experience / Minimum Qualifications: <ul><li>Bachelor’s degree in Mechanical Engineering or similar.</li><li>5+ years of experience in a similar role.</li><li>Team management experience.</li></ul> Required Skills and Competencies: <ul><li>Proficiency in design software (CAD): Creo (Pro-E), SolidWorks, Space Claim, AutoCAD, CATIA (preferably).</li><li>Proficiency in machining software (CAM): Creo ProNC, Mastercam, SolidCam (preferably).</li><li>Proficiency in plastic filling simulation software (CAE): Moldflow, Autodesk Moldflow, ANSYS.</li><li>Basic knowledge of plastic injection molding processes.</li><li>Strong knowledge in tool manufacturing, tool steel application/selection, heat treatment, and plating/coating.</li><li>Strong understanding of polymer technology, particularly engineering-grade resins.</li><li>Knowledge of Scientific Injection Molding and/or Mastermolding Certification (desirable).</li><li>Knowledge of Six Sigma and LEAN principles.</li><li>Knowledge of geometric tolerances.</li><li>Strong project management skills, with the ability to handle multiple projects simultaneously.</li><li>Understanding of practices, terminology, and tolerances associated with manufacturing, machining, grinding, wire EDM, casting, etc.</li><li>Availability to travel (25% of the time).</li><li>Proficiency in Microsoft Office Suite.</li><li>Knowledge of SAP.</li><li>Ability to exercise effective leadership.</li><li>Ability to read specialized reports (scientific and technical papers, legal reports).</li><li>Intermediate - Advanced English proficiency (85%).</li><li>Applicable knowledge for the position in IATF 16949 and ISO 14001.</li><li>Knowledge of the company’s safety regulations and environmental management system.</li></ul>

Responsibilities: <ul><li>Lead a team of customer-facing quality engineers to provide root cause analysis and corrective action communications to our customers during quality issues within our target timeframes.</li><li>Utilize formal problem-solving techniques to resolve product and process-related issues, leading cross-functional teams.</li><li>Lead cross-functional Notice of Escape teams to ensure containment, root cause analysis, corrective action, and communication to customers.</li><li>Evaluate customer requirements during order processing, drive implementation of new customer-specific requirements, and negotiate requirements not in the best interest of the company.</li><li>Design and develop forms and instructions for recording, evaluating, and reporting quality data.</li><li>Review and approve First Article reports.</li><li>Work cross-functionally to disposition nonconforming product found at incoming, in process, or returned from customers and approve any deviations required.</li><li>Support direct reports through coaching, development, and prioritization of responsibilities. Hold direct reports accountable for results and task completion.</li></ul> Requirements: <ul><li>Bachelor’s Degree required in a related field such as Engineering, Quality, or Reliability Engineering.</li><li>7+ years of industry experience, including 2+ years supervising others.</li><li>Up to 10% travel may be required, including international travel.</li><li>Excellent presentation skills, along with strong written and verbal communication skills.</li><li>Must possess strong problem-solving skills. Advanced problem-solving tools such as Lean Six Sigma Green Belt or Shainin Red X Journeyman are a plus.</li><li>Excellent negotiation skills both internally and externally to drive completion of 8D documents that advance the organization toward world-class manufacturing.</li><li>Experience leading problem-solving teams and using tools such as 8D, 5-Why Analysis, and Fishbone Diagrams.</li><li>Working knowledge of quality systems in an ISO9001/AS9100 environment is a plus.</li><li>Strong computer skills, including proficiency in SAP, Microsoft Word, Excel, and PowerPoint.</li></ul>

Responsibilities: <ul><li>Responsible for building capabilities through the deployment of the AM COE to enable standard process standards to be embedded and drive improved and sustainable operational results within the site.&nbsp;</li><li>Facilitate monthly performance AM CoE review with the site AM CoE members.&nbsp;</li><li>Participate in monthly KWS call with the Regional Lead of AM CoE.</li><li>Lead governance process to ensure the effective delivery of the AM program and activities.</li><li>Actively engage with the Regional CoE lead to devise strategy and execution of existing and future AM CoE Phase development and deployment.</li><li>Ensure the use of AM tools are being adopted to drive business process excellence and deliver business results, while developing, training, and supporting cross functional teams across the site on AM tools.</li><li>Support the implementation of Digitalization on AM apps at site level.&nbsp;</li><li>Provide training on AM CoE tools.&nbsp;</li><li>Set targets and ensure key performance metrics are available to be published for AM, updating key stakeholders on a regular basis, escalating issues accordingly to the appropriate channels.&nbsp;</li><li>Ensures the use of best practices and applies lessons learned from previous projects; shares lessons learned with other project management team members. Prove linkage of key performance indicators to business process effectiveness. Document and institutionalize controls.&nbsp;</li><li>Responsible for supporting the execution of relevant projects within assigned area / shift.</li><li>Responsible for monitoring, analysis and keeping the control of the process for the line by strict monitoring and variation analysis of the production plan.</li><li>Ensures that the personnel comply with Safety and Food Safety regulatory requirements throughout their lines.</li><li>Accountable for participating in the Safety Seven program by performing the Gemba walks while ensuring that operations personnel comply with all the policies, programs and activities focused on preventing injuries, sickness and environmental sustainability. All this, through safe behaviors, K-Value alignment and the belief that all injuries are preventable.</li><li>Accountable for participating &amp; close on the identified actions from the Gemba walks (Golden Six) and participates in the scheduled walks.</li><li>Responsible for complying with good manufacturing practices. If a food safety variation is identified, this person is responsible for final reporting together with Line Manager and following up on corrective actions after agreement with relevant department such as QA, Engineering &amp; Technical team.</li><li>Ensures the implementation and follow up of actions resulting from root cause analysis, enabling problem-solution sessions related to the equipment and continuous improvement.</li><li>Active participation, analyses &amp; understand with other COE’s, all the line shutdowns, variations, OEE Trends, waste and generates action to avoid them.</li><li>Leads improvement projects for the line oriented to generate savings and increase productivity to directly impact the OEE and comply with the plant savings pipeline.</li><li>Responsible for giving weekly and monthly visibility of all activities related to their line by giving service needs for their lines, therefore job planned accordingly.</li><li>Ensures compliance with the company Work Systems (KWS) culture across all Supply Chain functions to enhance ways of working driving towards being KWS compliant Manufacturing Plant.</li><li>Responsible for managing the operation team (HR process): vacation, absence, leaves, extra hours, as well as execution of disciplinary actions.</li><li>Ensures the technical and leadership competency development of their Shift Managers &amp; development of the operative personnel.</li><li>Maintains high motivation, productivity and work environment levels among the production personnel by establishing and keeping permanent contact and good communication to identify their needs and concerns.</li><li>Other duties as assigned.</li></ul> Requirements: <ul><li>This position requires the applicant who is tertiary educated in a manufacturing or other supply chain operations discipline.</li><li>Demonstrated ability to manage complexity coupled with strong problem solving, negotiating, and decision-making skills.</li><li>Strong knowledge of manufacturing within a FMCG operation.</li><li>Experience in implementing lean manufacturing techniques., AM, continues improvements tools in processes.</li><li>Strong people management is required coupled with the ability to work cross functionally across the organization.&nbsp;</li><li>Able to communicate and influence at all levels of the organization.</li></ul>

Responsibilities: <ul><li>Lead KWS RM COE and own equipment criticality element as part of the facilities and utilities operation.</li><li>Lead Facilities &amp; Utilities team insourcing maintenance strategy with a strong technical development plan</li><li>Delivery highest level of facilities and utilities machine reliability with the optimum level of preventive, corrective &amp; condition-based base maintenance strategic formulation and implementation.</li><li>Lead and implement integrated facilities management for factory-wide facilities management/maintenance. This includes the hard and soft service of the facilities management.&nbsp;</li><li>Key member and element owner of Technical COE on FUS and drive all global FUS programs.</li><li>Key member of NRC COE to drive sustainability agenda through out the factory.</li><li>Develop good relationships with other regional factories and strive for cross-learning and implementation of best practices for plant performance and KWS.</li><li>Owns engineering facilities and utilities R&amp;M cost budgeting and end-to-end management and monitoring.&nbsp;</li><li>Conducts effective cost reduction initiatives in line with ZLA &amp; KIMMS projects.&nbsp;&nbsp;</li><li>Leads ongoing cross-functional teams to conduct analyses of plant savings opportunities, identify CAPEX investment opportunities, and make strategic investments to support growth and machine reliability.</li><li>Provide coaching, and guidance &amp; lead the team towards a high-performing team.</li><li>Leads the team as the expert point of contact for facilities and utilities for the whole plant and provides support accordingly.</li><li>Owns Technician Training and development systems in support of Technician Progression</li><li>Responsible for Site Daily Meeting Cadence with Tier 1-4 meetings and ensure they are healthy for results sustainability.</li><li>To guard standards and regulations on EHS, QFS, and other fundamentals by participating in and coaching during Leader Led Observations, Safety 7, Golden 6, and other EHS and QFS activities.&nbsp;</li><li>Always maintain a good level of documentation and evidence management to support all internal and external audits. (QFS, KWS, EHS, DOSH, FSSC, HACCP, HALAL, and Global programs on FUS)</li></ul> Requirements: <ul><li>Degree in Chemical/Mechanical/Electrical Engineering or related discipline with at least 10 years of working experience.</li><li>Sound practical knowledge of mechanical engineering (rotating equipment, fasteners, bearings, gearbox, valves, thermodynamics, material strength &amp; compatibility, etc.)</li><li>Sound technical knowledge of utilities &amp; facilities equipment working mechanism and working principle (compressed air, WWTP, HVAC, chiller, coiler, hoist, rapid door, building maintenance (roof, drain, floor, etc.), electrical power supply, water supply, gas supply, nitrogen gas supply, etc.)</li><li>Preferably having work experience in F&amp;B industries with experience in SAP system</li><li>Technical experience in the following systems:&nbsp;</li><li>Six Sigma DMAIC process and strong analytical knowledge to lead and resolve complex issues.</li><li>Strong knowledge and awareness of different types of leadership and hands-on experience.&nbsp;</li><li>Capable of formulating different types of strategies to increase reliability, effectiveness, and collaboration of facilities and utilities teams to drive results in a sustainable way</li><li>Numerical literacy of basic electrical engineering (motor power, electrical load, cable sizing) and process engineering (basic mathematics related to the physics of pressure, temperature, level, force, etc.)</li><li>Sound hands-on experience in facilities &amp; utilities maintenance strategy formulation and conducting insourcing maintenance.&nbsp;</li><li>Exposed and have hands-on experience with pillar approached performance management (KWS), CI tools, analysis tools, sound problem-solving skills, and coaching skills.</li><li>Six Sigma Green Belt project implementation experience &amp; CAPEX project management will be an added advantage</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>

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15 dmaic six sigma Jobs found

Manager, Operations

Senior Quality Specialist

Sr Quality & Reliability Engineer

Manufacturing & Process Development Engineer II (Wire & Cable)

Assistant Manager, Continuous Improvement

Sr. MFG & Process DVL Engineer

Quality Engineering Supervisor

Line Manager (Improvement)

Facilities & Utilities Manager

Site Investigation Lead, Quality Assurance

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15 dmaic six sigma Jobs found

Manager, Operations

Senior Quality Specialist

Sr Quality & Reliability Engineer

Manufacturing & Process Development Engineer II (Wire & Cable)

Assistant Manager, Continuous Improvement

Sr. MFG & Process DVL Engineer

Quality Engineering Supervisor

Line Manager (Improvement)

Facilities & Utilities Manager

Site Investigation Lead, Quality Assurance

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

EMPLOYER

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