QA Specialist - Quality Assurance

About the role

Pfizer is hiring a QA Specialist in its Quality Assurance and Control function. The role reviews and approves batch records, cleaning and GMP documents, and helps keep the site ready for regulatory inspections, supporting the delivery of safe and effective products to patients.

Key responsibilities

• Review and approve master batch records and completed batch records for the manufacture, packaging and labelling of intermediates and APIs, against quality standards and regulatory specifications.
• Perform disposition of intermediates and APIs.
• Review and approve cleaning instructions and records, and GMP documents such as SOPs, protocols, reports and change controls.
• Ensure compliance with quality procedures, regulatory requirements and cGMP.
• Review and approve deviations, including investigation reports, root cause analyses, CAPAs and quality, validation, stability and regulatory impact assessments.
• Maintain quality tracking systems and metrics, prepare Annual Product Records and support inspection readiness and regulatory submissions.
• Take part in GMP walkdowns, maintain the validated state of GMP systems, support EHS investigations and contribute to continuous improvement of QA systems.

Required profile

• Diploma with at least 4 years of relevant experience, or a BA/BS with at least 1 year of relevant experience.
• Experience in the pharmaceutical industry and in quality administration systems.
• Team player with effective written and oral communication skills.

Required skills

• Sound knowledge of current Good Manufacturing Practices (part of GxP).
• Preferred: manufacturing site experience, deviation management, batch record review, ERP systems, non-conformance investigation, root cause analysis and change control.