QC Laboratory Manager (Operations)

QC Laboratory Manager (Operations)

Pfizer Asia Pacific Pte Ltd
Singapore
Not Specified
Not Specified

Job Description


Job Description :
Why Patients Need You
Everything 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 Achieve
You 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 (QC) 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 Research and Development (R&D).
As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.
It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It
  • Manage and ensure the provision of chemical and microbiological analytical services to internal/external customers to ensure that all starting materials/water samples/intermediates and final products are analyzed and tested accordingly to the stipulated quality and regulatory requirements so as to provide accurate test results for correct GMP usage decisions
  • Ensure QC tiers are well managed and quality, operational safety issues, standard works, escalations and non-conformance are tracked to ensure prompt closure on time.
  • Develop and manage the operating budget and capital expenditure proposal for the laboratory to ensure achievement of operational targets.
  • Ensure a safe working environment for the laboratory. Lead initiatives to improve safety performance and colleague engagement.
  • Work closely with the relevant process owners (i.e Production, Procurement, Supply Chain, Warehouse, Process Development) for the introduction of new starting materials sources.
  • Oversight of all non-conformance within the QC laboratory to ensure that investigations carried out are in-depth, consistent in quality and comply with Pfizer PQS.
  • Ensure that CAPAs implemented are systematic and effective to address root cause identified.
  • Ensure the product stability programs are managed and stability data is reported for Annual Product Review Reports (APPR) and regulatory filing in a timely manner.
  • Manage, develop, and motivate staff to help realized their maximum potential to contribute towards achieving the site objectives.
  • Coach and Mentor QC investigators in different investigation methodology.
  • Monthly trending of non-conformance in QC and presentation to SQRT for any adverse trends

  • Job Related Requirements
  • Excellent verbal, written and interpersonal communication skills
  • Demonstrated ability to interact effectively with senior management, QA/QC colleagues, auditor and regulators
  • Thorough knowledge and understanding of GMP, GLP, GDP , Data Integrity and PQS for non-conformance management.
  • Good knowledge of analytical chemistry, instrumentation , laboratory automation and production processes.
  • Good interface with different stakeholders (Production, QC Operations, IMEX) to ensure that CAPA implemented are aligned with operational requirements.

  • Accountabilities:
  • QC testing and compliance to GMP
  • QC laboratory operating budget and capital expenditure
  • Laboratory safety programs
  • Regulatory and compliance requirements
  • Non conformance (LIR, RAAC, QUA, Events) management and prompt closure within timeline.
  • Quality of investigation
  • Standard Operating Procedure (SOPs) development and review
  • Staff development and performance review.
    Key Performance Indicator
  • Testing of samples within the Service Level Agreement
  • Compliance to cGMP and audit performance
  • Prompt closure of non-conformances within 30 days ,COT
  • Reduction in recurring non-conformance
  • Improvement in Analytical Right First Time (ARFT)
  • Stability program adherence

Qualifications
  • Bachelor's Degreein Science (Chemistry preferred) or Life Science relating to Chemistry, Pharmacy, Pharmaceutical Science or Microbiology or a related science.

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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Others , IT , Telecom / ISP , Operations

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

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