Biopharmaceutical Quality Expert

5 days ago

Singapore beBeeQuality Full time $800,000 - $1,000,000

This comprehensive career advancement program is designed to equip participants with the necessary skills and expertise to excel in the biopharmaceutical manufacturing sector.

Program Overview
  • Duration: 15 months
  • Attachment: Local attachment to Pfizer Inc.
  • Eligibility:
    • Singapore Citizens or Singapore Permanent Residents
    • No prior working experience in the biopharmaceutical sector
    • Mid-Career Candidate: Graduated for at least 2 years prior to point of application
  • Training Allowances: CPF exempted
The Program Benefits

This distinguished talent development initiative aims to cultivate the next generation of skilled professionals for Singapore's biopharmaceutical manufacturing industry. Participants will gain valuable knowledge and skills, as well as have the opportunity to network with industry experts.

The Role

The incumbent is a member of the Quality Assurance team. Key responsibilities include promoting quality culture and GMP compliant behaviors at the site, ensuring compliance to Pfizer Quality Standards (PQS) and ICH guidelines, and providing quality oversight to vendor management.

Key Responsibilities
  • Review and approve GMP documentation to ensure their compliance with PQS.
  • Qualify and manage vendors according to PQS and maintain accurate records of vendor status. Review and analyze the quality related issues from vendors and recommend improvement actions to mitigate compliance risks. Ensure vendors and materials are qualified as required to support production schedule.
  • Conduct internal audits to ensure internal controls are effective. Conduct external audits to ensure adequate oversight to vendors and collaborate with vendor to reduce material quality issues.
  • Manage logistics for internal and external GMP inspections, including site communications and training.
  • Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state and adhere to site procedures and PQS.
  • Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner.
  • Ensure gap analysis of site procedures against PQS is performed by relevant SMEs in a timely manner meeting requirements for rollout of new / updated PQS / Policy Memos.
  • Participate in gap analysis of site procedures against PQS and propose required actions to address identified gaps and mitigate risks.
  • Maintain current quality tracking systems and quality metrics to proactively identify trends and atypical observations.
  • Support preparation and/or coordination of site monthly and adhoc Site Quality Review Team (SQRT) meetings.
  • Uphold Pfizer's code of conduct and values.
  • Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations.
  • Collaborate with cross-functional teams to drive flawless execution.
  • Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).
Requirements

Requirements include strong verbal, written communication and presentation skills, demonstrated ability to perform in a team, can-do attitude, and embracing the use of digital technology to scale and speed up every form of interaction and action. Experience within the pharmaceutical industry and degree in Chemistry, Microbiology, Engineering or other Science related discipline is also required.

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