Associate Manager Materials Laboratory

Job Description

Why Patients Need YouEverything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.What You Will AchieveYou will be a member of Pfizer?s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to patients.Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from R&D.As a Team lead, you will be involved in leading work teams within your division, including the technical and financial resources of the team. Thanks to your technical skills, you will coach your direct reports on day to day activities. You will be relied on to solve complex problems within your area of expertise.It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It

• Supervise and prioritize sampling and testing need with close co-ordinate with planning team to avoid stock out due to testing delay and ensure timely materials release.
• To manage the sampling activity of raw materials (API / excipient) and imported bulk in RM s.
• To manage the sampling activity of primary, secondary and tertiary packaging materials in Packaging store.
• To manage the routine sample and assign the daily routine work to material team.
• To manage the Visual status label of Raw and Packaging material.
• To manage the retention sample of raw and packaging material with tracking numbers.
• To ensure that analyst documentation is completed and verified before archiving.
• Ensure that all analytical data of regular materials and import bulk are entered in LIMS.
• To Ensure all OOS and OOT results are notify to the QC manager and entered in QTS on time and implementation of CAPA actions (if required).
• To revise / update and manage the SOPs of QC Lab as per PQS requirement with 100 % adhere and their implementation.
• Ensure / give training to the analysts on SOP, materials testing, Instrument handling / Instrument verification /Calibration.
• To ensure the training records of newly hired analyst are completed on time and submitted to training department.
• Provide leadership/direction to staff, and responsible for performance management and growth and development of staff.
• Manage multiple projects and ongoing work activities within a work team and ensure agreed upon timelines are met.
• Oversee and review/approve investigations, CAPA (Corrective Action and Preventive Action) and change controls.
• Review laboratory data to ensure compliance with approved methodologies.
• Build capabilities of the Process-Centric Team according to skills needs assessments.
• Serve as a point of contact for issues related to laboratory applications and core solutions.
• Engage with business partner to identify areas of improvement across laboratory and core applications and processes.
• Provide technical expertise and support to the QC laboratory for laboratory and core applications.
• Manage review and approval of Good Manufacturing Practices {also cGMP} documentation, such as procedures, data and reports.

QualificationsMust-Have

• Bachelors Degree
• 3+ years? experience
• Laboratory supervisory experience
• Knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories
• Experience with leading colleagues and/or projects
• Strong people management experience
• Demonstrated skills in collaboration, attention to detail, and communication skills
• Ability to handle complex and detailed situations with a focus on quality

Nice-to-Have

• Masters degree
• Relevant pharmaceutical experience.
• Knowledge of Laboratory Information Management System, Empower and Microsoft Office
• Working knowledge and understanding of requirements as it relates to method qualification and testing of components and finished products

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Quality Assurance and Control#LI-PFE

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