EUC Consultant M365

Safety, Health & Environment Manager

Lead business Partner Supply Chain - Enterprise Systems - AMEA

Sales Manager – Device Business (South Zone)

Sales Manager – Device Business (East Zone)

Manager, Analytical Quality Assurance

Sr. EHS Site Manager

EHS Manager

Human Resource Manager

Site Investigation Lead, Quality Assurance

Responsibilities: <ul><li>Setup and Configuration. Deploy and configure M365 services, including Teams, Exchange Online, Windows 10/11 Deployment and Intune.</li><li>Implement security and compliance policies to ensure data classification and compliance.</li><li>Conduct Proof of Concept (POC), new product evaluations and fitment.</li><li>Configure and manage user accounts, licenses, and permissions.</li></ul> Management and Operation: <ul><li>Monitor and maintain the health and performance of M365 services.</li><li>Troubleshoot and resolve issues related to M365 services and applications.</li><li>Perform regular updates and maintenance to ensure optimal performance and security.</li></ul> Collaboration and Support: <ul><li>Work closely with other IT teams to integrate M365 services with existing systems and applications.</li><li>Provide technical support and guidance to end-users and other IT staff.</li><li>Conduct training sessions and create documentation to help users effectively utilize M365 services.</li></ul> Continuous Improvement: <ul><li>Stay up-to-date with the latest M365 features, updates, and best practices.</li><li>Identify opportunities for process improvements and automation to enhance efficiency and productivity</li><li>Participate in the planning and lead execution of M365-related projects and initiatives.</li></ul> Requirements: Additional Requirement details - Microsoft 365 Certified: <ul><li>Enterprise Administrator Expert or other relevant certifications.</li><li>roven experience in setting up, configuring, managing, and operating M365 tenant and workloads.</li><li>Strong knowledge of Microsoft 365 services, including Teams, Exchange Online, Windows 10/11 Deployment and Intune.</li><li>Experience with PowerShell scripting for automation and management tasks.</li><li>Experience with hybrid M365 environments and integration with on-premises systems.</li><li>Familiarity with security and compliance features in M365, such as Data Loss Prevention (DLP), Conditional Access, and Multi-Factor Authentication (MFA).</li><li>Knowledge of Azure Active Directory and related identity management solutions.</li><li>Excellent problem-solving and troubleshooting skills.</li><li>Strong communication and interpersonal skills.</li><li>Ability to work independently and as part of a team.</li></ul> Educational Qualification: <ul><li>Bachelor’s Degree in Computer Science, Information Technology or related field</li></ul> Experience: <ul><li>Minimum 5 to 6 years in EUC environment.</li><li>2 to 3 years of experience with skilled and experienced M365 Engineer and responsible for setting up, configuring, managing, and operating our M365 tenant and workloads. This role requires a deep understanding of Microsoft 365 services.</li></ul>

Responsibilities: Site Safety Management:&nbsp; <ul><li>Lead daily site-based safety activities, including risk assessments, toolbox talks, and audits.</li></ul> Regulatory Compliance:&nbsp; <ul><li>Ensure full compliance with Taiwan’s construction safety regulations and relevant international standards.</li></ul> Incident Response:&nbsp; <ul><li>Manage incident investigations, corrective actions, and reporting procedures.</li></ul> Contractor Oversight:&nbsp; <ul><li>Monitor and enforce safety standards for contractors and subcontractors on-site.</li></ul> Documentation &amp; Audits:&nbsp; <ul><li>Maintain accurate SH&amp;E records and support both internal and external audits.</li></ul> Project Exposure: <ul><li>Operate across high-rise, industrial, commercial, or infrastructure construction environments.</li></ul> ﻿Requirements: <ul><li>Experience: 7+ years in construction or engineering environments, with hands-on SH&amp;E responsibilities; experience supporting both office-based and site-based operations.</li><li>Skills: Proficient in risk assessments, incident investigation, subcontractor safety oversight, SH&amp;E training delivery, and internal/external audit preparation.</li><li>Certifications: NEBOSH, ISO 45001 Internal Auditor, or Taiwan OSH license preferred.</li><li>Knowledge: In-depth understanding of Taiwan construction safety laws and international SH&amp;E standards; experience in aligning local operations with regional programs.</li><li>Language: Bilingual in Mandarin and English to effectively operate in multinational environments and communicate with local and regional stakeholders.</li><li>Location: Based in Taipei or willing to relocate; must be able to support project sites across Taiwan (only local Taiwanese can be considered)&nbsp;</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: <ul><li>Develop and implement zonal sales strategies aligned with national goals.</li><li>Monitor sales performance and ensure monthly / quarterly / yearly sales target is achieved.</li><li>To work closely with employees of dealers to generate leads, ensure demonstration of devices and close sales.</li><li>Establish dealers’ infrastructure to drive the business in private and government sectors.</li><li>Build and maintain strong relationships with dealers and key accounts.</li><li>To conduct regular field visits for developing KOLs, identify new market opportunities, engaging with key customers (hospitals, clinics, healthcare professionals) to build long-term relationships.</li><li>Plan, coordinate, and execute the zonal rollout of newly launched medical devices.</li><li>Collaborate with the marketing team to ensure effective market introduction .</li><li>Conduct training programs for internal sales teams and channel partners on new product features, benefits, and usage.</li><li>Track performance of new products post-launch and provide feedback to marketing.</li><li>Medical devices portfolio includes Point of Care Ultrasound device from Butterfly. We also plan to expand this portfolio to include Butterfly Vet, along&nbsp;</li><li>With future offerings in the Cardiology, Neurology, and Gynaecology segments.</li></ul> Requirements: <ul><li>Minimum Graduate with Science Background preferably.</li><li>Expertise on consultative selling.</li><li>Ready to cover and manage large Geographies.</li><li>Professional driven by values and science.</li><li>Knows the business development process.</li><li>Aspire to learn and discuss new technologies</li><li>Ready to take the challenges for establishing new products and technologies.</li><li>The person should have a minimum of 12 to 14 years of experience working in the medical device industry in the South Zone handling capital equipment.</li><li>Preferably from Critical care, intensive care, anesthesia, Cardiology background.</li></ul>

Responsibilities: <ul><li>Develop and implement zonal sales strategies aligned with national goals.</li><li>Monitor sales performance and ensure monthly / quarterly / yearly sales target is achieved.</li><li>To work closely with employees of dealers to generate leads, ensure demonstration of devices and close sales.</li><li>Establish dealers’ infrastructure to drive the business in private and government sectors.</li><li>Build and maintain strong relationships with dealers and key accounts.</li><li>To conduct regular field visits for developing KOLs, identify new market opportunities, engaging with key customers (hospitals, clinics, healthcare professionals) to build long-term relationships.</li><li>Plan, coordinate, and execute the zonal rollout of newly launched medical devices.</li><li>Collaborate with the marketing team to ensure effective market introduction.</li><li>Conduct training programs for internal sales teams and channel partners on new product features, benefits, company</li><li>Track performance of new products post-launch and provide feedback to marketing.</li><li>Medical devices portfolio includes Point of Care Ultrasound device from Butterfly. We also plan to expand this portfolio to include Butterfly Vet, along with future offerings in the Cardiology, Neurology, and Gynaecology segments.</li></ul> Requirements: <ul><li>Minimum Graduate with Science Background preferably.</li><li>Expertise on consultative selling.</li><li>Ready to cover and manage large Geographies.</li><li>Professional driven by values and science.</li><li>Knows the business development process.</li><li>Aspire to learn and discuss new technologies</li><li>Ready to take the challenges for establishing new products and technologies.</li><li>The person should have a minimum of 12 to 14 years of experience working in the medical device industry in the East Zone handling capital equipment.</li><li>Preferably from Critical care, intensive care, anesthesia, Cardiology background</li></ul>

Responsibilities: Accountability AQA Management <ul><li>Manage all Analytical and Quality Control (QC) activities to ensure compliance with cGMP, FDA, EMA, and ICH guidelines.</li><li>Lead a team of data reviewers, ensuring accurate, complete, and timely review of raw data, analytical results, and laboratory documentation.</li><li>Supervise the Stability Program and Coordinator, including protocol approval, sample pull scheduling, data review, and reporting.</li><li>Ensure analytical data integrity through implementation and oversight of robust review processes and audit trails.</li><li>Collaborate with QC, QA, and R&amp;D departments to support method validations, transfers, and investigations.</li><li>Review and approve analytical documentation such as CoAs, method validation/verification protocols and reports, and stability summaries.</li><li>Lead or support investigations into out-of-specification (OOS), out-of-trend (OOT), deviations, and laboratory incidents.</li><li>Support regulatory inspections and internal/external audits, providing documentation and subject matter expertise.</li><li>Drive continuous improvement initiatives in QA/QC processes and systems to ensure operational excellence and regulatory readiness.</li><li>Mentor, coach, and develop the AQA team to build a high-performing quality organization.</li></ul> Workload Management <ul><li>Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</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> SOPs <ul><li>Review/Approve SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li></ul> Staff Development <ul><li>Evaluate potential candidates for QA, performance evaluation of direct reports.</li><li>Coordinate data review for analytical tests, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing.</li></ul> Requirements: Qualifications Education &amp; Experience <ul><li>Bachelor’s degree in chemistry, Pharmaceutical Sciences, or related field (master’s or Ph.D. preferred).</li><li>Minimum of 10 years of experience in pharmaceutical analytical quality assurance or quality control.</li><li>Proven leadership or supervisory experience in a GMP-regulated environment.</li><li>Experience with analytical instrumentation (HPLC, GC, UV, IR, etc.) and associated data review.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills..</li></ul> Knowledge <ul><li>Strong understanding of FDA regulations, cGMP, ICH guidelines, USP/EP compendia.</li><li>Knowledge of pharmaceutical manufacturing processes and laboratory practices.</li><li>Familiarity with regulatory submission requirements (ANDA, NDA, etc.).</li><li>Proficiency with laboratory software and documentation systems (e.g., Empower, LIMS, TrackWise).</li></ul> Skills &amp; Abilities <ul><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>Strong attention to detail with a commitment to quality and compliance.</li><li>Effective leadership, team management, and interpersonal communication.</li><li>Ability to prioritize and manage multiple tasks in a fast-paced environment.</li><li>Proficient in technical writing and reviewing complex data and reports.</li></ul> Physical Requirements <ul><li>Ability to sit or stand for extended periods.</li><li>Occasionally lift up to 25 pounds.</li><li>Use of personal protective equipment (PPE) as required in laboratory or production areas.</li><li>Ability to work in office, laboratory, and manufacturing settings as needed.</li><li>The work environment is representative of a group laboratory environment.</li></ul>

Responsibilities:&nbsp; <ul><li>Lead and manage the Wilsonville site’s EHS&amp;S team and programs.</li><li>Ensure compliance with local, state, and federal environmental and safety regulations including OSHA, EPA (CAA, CWA, RCRA, TSCA, SARA), and our client internal standards.</li><li>Develop, implement, and monitor EHS performance metrics and reports for internal and external stakeholders.</li><li>Drive continuous improvement in areas such as Behavior-Based Safety (BBS), ergonomics, hazardous waste, machine safety, and energy reduction.</li><li>Maintain and manage environmental permits, licenses, and records.</li><li>Oversee incident investigation and corrective action programs.</li><li>Act as the primary contact for regulatory agencies and third-party auditors.</li><li>Manage the EHS&amp;S budget and related capital projects.</li><li>Support ISO 14001 environmental management system implementation and certification.</li><li>Promote employee engagement and awareness across the site through training, communications, and EHS culture-building activities.</li><li>Coordinate sustainability initiatives targeting Scope 1, 2, and 3 emissions, water usage, and waste reduction.</li><li>Engage with site leadership in operations, maintenance, quality, and procurement to ensure integrated EHS compliance and strategy.</li><li>Stay abreast of regulatory changes and adapt internal policies accordingly.</li></ul> Requirements: Qualifications&nbsp; <ul><li>Bachelor’s degree in Environmental, Health &amp; Safety or related field (required).</li><li>10+ years of EHS experience in a manufacturing environment.</li><li>Experience in medical device manufacturing or similarly regulated industry preferred.</li><li>CSP (Certified Safety Professional) preferred.</li><li>Experience implementing and managing EHS systems and ISO 14001 certification.&nbsp;</li></ul>

Responsibilities: <ul><li>Lead all EHS&amp;S initiatives at the Medway site.</li><li>Build and maintain a strong safety culture across departments.</li><li>Ensure compliance with federal, state, and local regulations including OSHA, EPA (CAA, CWA, RCRA, TSCA, SARA), and internal our client standard.</li><li>Develop and implement EHS programs, training, and internal audits.</li><li>Manage environmental permits, licenses, and waste disposal practices.</li><li>Coordinate emergency preparedness and hazardous material controls.</li><li>Lead incident investigations and root cause analysis.</li><li>Maintain ISO 14001 certification and drive continuous improvement.</li><li>Prepare EHS reports and metrics for internal and external stakeholders.</li><li>Represent the site during audits by customers and regulatory agencies.</li><li>Oversee EHS budget and manage third-party consultants or vendors as needed.</li></ul> Requirements: Qualifications &amp; Experience&nbsp; <ul><li>Bachelor’s degree in Environmental, Health &amp; Safety or related field (required).</li><li>7+ years of EHS experience in a manufacturing environment.</li><li>Experience in medical devices or other highly regulated industries preferred.</li><li>CSP (Certified Safety Professional) certification preferred.</li><li>Experience with ISO 14001 implementation.</li><li>In-depth knowledge of hazardous waste, air/water compliance, chemical management, and emergency response protocols.</li></ul>

Responsibilities: <ul><li>Live, lead, and embed an organizational culture that aligns to the company Way</li><li>Collaborate with senior leadership to develop HR strategies that align and support the execution of the long-term organizational goals and objectives</li><li>Plan, lead, develop, coordinate, and implement HR policies, processes, and initiatives, to drive the organization’s HR compliance and strategic needs</li><li>Oversee the administration of strategic HR programs including, but not limited to talent acquisition, talent management, rewards, performance management, employee engagement and learning and development</li><li>Advise management on the legal ramifications of employment decisions, including hiring, disciplinary actions, terminations, and policy changes, to mitigate legal risks and ensure compliance with labour laws and internal policies.</li><li>Ensure company compliance with all applicable labour laws, government regulations, and statutory requirements, including timely implementation of updates to labour standards, occupational health and safety rules, and other employment-related legislation</li><li>Analyze organizational trends to improve employee engagement, organizational performance and process improvements</li><li>Maintain knowledge of trends, best practices in human resources, talent management, and employment law; apply this knowledge to communicate changes in policy, practice, and resources to leadership and wider organization</li><li>Manage and coach the HR team to deliver exceptional service and support; providing professional development opportunities to upskill and increase capabilities, skills, knowledge and expertise</li><li>Lead the year-end tax annualization process by ensuring accurate computation, reconciliation, and reporting of annual withholding tax for all employees in compliance with BIR regulations&nbsp;</li><li>Develop and manage the HR operational budget</li><li>Work with company team in the US on key projects to standardize HR practices across entities</li><li>Perform other duties as required</li></ul> Requirements: <ul><li>Bachelors Degree in a related field required</li><li>MBA preferred</li><li>10+ years’ relevant HR experience, of which at least 5 years directly leading HR teams&nbsp;</li><li>Experience working in a manufacturing environment is a must. Experience of working in FMCG industry is preferred&nbsp;</li><li>Experience in a multinational corporation preferred</li><li>Demonstrated experience in developing, leading and managing programs/projects and process improvements in talent acquisition, performance management, compensation and benefits, talent development and employee engagement</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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30 health benefits consultant Jobs found

EUC Consultant M365

Safety, Health & Environment Manager

Lead business Partner Supply Chain - Enterprise Systems - AMEA

Sales Manager – Device Business (South Zone)

Sales Manager – Device Business (East Zone)

Manager, Analytical Quality Assurance

Sr. EHS Site Manager

EHS Manager

Human Resource Manager

Site Investigation Lead, Quality Assurance

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30 health benefits consultant Jobs found

EUC Consultant M365

Safety, Health & Environment Manager

Lead business Partner Supply Chain - Enterprise Systems - AMEA

Sales Manager – Device Business (South Zone)

Sales Manager – Device Business (East Zone)

Manager, Analytical Quality Assurance

Sr. EHS Site Manager

EHS Manager

Human Resource Manager

Site Investigation Lead, Quality Assurance

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

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