Jobfoundry
Jobfoundry
Pfizer

QA Specialist (Compliance) (PCP) 15 months training programme

Pfizer
BiopharmaSingapore - TuasFull-time5 days ago
Apply Now

About the role

AI summarised

This is a 15-month training program for a QA Specialist (Compliance) at Pfizer's API manufacturing site in Singapore, part of a government-sponsored career progression program for individuals with no prior biopharmaceutical experience. The role involves ensuring GMP compliance, managing vendors, conducting audits, and supporting regulatory inspections.

BiopharmaFull-time

Key Responsibilities

  • Review and approve GMP documentation to ensure their compliance with PQS/Global Policies/Global SOPs/Global Work Instructions.
  • Qualify and manage vendors according to PQS/Global Policies/Global SOPs/Global Work Instructions and maintain accurate records of vendor status.
  • Review Supplier Corrective Action Report (SCAR)/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/Global Policies/Global SOPs/Global Work Instructions.
  • 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 Quality Management Review (QMR) meetings.
  • Uphold Pfizer's code of conduct and values.

Requirements

  • Degree in Chemistry, Microbiology, Engineering or other Science related discipline.
  • Strong written and oral communication skills.
  • Demonstrate ability to act independently to resolve issues, with appropriate escalations (as required).
  • Strong verbal, written communication and presentation skills.
  • Demonstrated ability to perform in a team.
  • Possess a can-do / pride to succeed attitude.
  • Embrace the use of digital technology to scale and speed up every form of interaction and action.
  • Singapore Citizens or Singapore Permanent Residents.
  • Have no prior working experience in the biopharmaceutical sector.
  • Fresh graduates are welcome to apply.
  • Mid-Career Candidate: Graduated for at least 2 years prior to point of application.