Quality Assurance Specialist

2 months ago


Singapur, Singapore Pfizer Full time
Job Summary

Pfizer is seeking a highly skilled Quality Assurance Specialist to join our dedicated team. As a key member of our quality assurance team, you will play a critical role in ensuring the quality and safety of our products.

Key Responsibilities
  • Drive quality culture and promote Good Manufacturing Practice (GMP) compliance behaviors across the site.
  • Ensure site compliance to Pfizer Quality Standards (PQS) and International Conference on Harmonisation (ICH) guidelines.
  • Provide quality assurance oversight to the site's GMP operations to ensure products are produced in compliance with Pfizer Quality Standards (PQS).
  • Collaborate with cross-functional teams to improve quality systems and processes.
  • Understand regulatory expectations and support site inspection readiness.
  • Work with the supply chain and drug product sites to ensure timely delivery of quality products.
  • Work with the Global Compliance and Manufacturing Control (GCMC) team to file products and address regulatory queries in an accurate and timely manner.
Requirements
  • Bachelor's Degree/Diploma in Science/Chemical Engineering or equivalent.
  • Experience in the pharmaceutical industry, with a focus on quality administered systems.
  • Sound knowledge of current Good Manufacturing Practices (GxP).
  • Ability to work in a team environment within own team and interdepartmental teams.
  • Effective written and oral communication skills.
Preferred Qualifications
  • Experience at a manufacturing site.
  • Experience of writing reports.
  • Experience in production batch record review, Enterprise Resource Planning system, campaign changeover, startup support, and change control management.


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