Quality Assurance Specialist
2 months ago
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.
- 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.
- 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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2 months ago
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