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The incumbent is a member of the Quality Assurance (QA) Operations team. Under the supervision of the Senior QA Manager / QA Manager, the incumbent will be responsible for providing QA oversight to ensure products produced are in compliance with Pfizer Quality Standards (PQS) and ICH guidelines, working with supply chain, supporting regulatory filings, driving quality culture and system improvements, and mentoring team members.
Job Responsibility:
Provide QA oversight to site operations (primarily Production, Quality Control, Warehouse, Engineering) to ensure products produced are in compliance with Pfizer Quality Standards (PQS) and ICH guidelines
Work with supply chain and downstream / drug product sites to ensure timely delivery of quality products
Support regulatory team to file products and address regulatory queries in an accurate and timely manner
Understand regulatory expectations and support site inspection readiness
Drive quality culture and promote GMP compliant behaviors at the site
Drive improvement of quality systems in collaboration with cross functional teams
Contribute to achieve our vision of being best in class manufacturing site, producing highest quality products in the safest way
Deploy and use Imex 'way of working' for day-to-day operations, problem solving, escalation and continuous improvements
Mentor members within the QA team
Requirements:
Degree in Chemistry, Microbiology, Engineering or other Science related discipline
Minimum 4 years experience (including QA roles) within the pharmaceutical industry
Compliance, regulatory or validation experience is an advantage
Strong written and oral communication skills
Technical report writing skills is an advantage
Demonstrated personal leadership, accountability, and organizational skills with proven ability to operate independently with minimal supervision
Experience working in a cross-functional, matrix environment is an advantage
Nice to have:
Compliance, regulatory or validation experience
Technical report writing skills
Experience working in a cross-functional, matrix environment