Associate Manager - Quality Assurance

Responsibilities

• Manage New Product Introduction (NPI) projects and ensure zero-defect technology transfers for new products into the site.
• Review and approve change controls, SOPs, validation protocols, PRQs, and PRs to ensure the full validation life cycle.
• Provide quality support and review for scale-up, pilot bio batches, and exhibit batches to meet regulatory expectations.
• Review process validation protocols, optimization reports, technology transfer reports, analytical data sheets, and stability data.
• Oversee project validation protocols, QRM, cleaning validation, and filter validation protocols and reports.
• Review Analytical Method Transfer and method validation reports to ensure consistency across transfer sites.
• Investigate and document Quality Assurance deviations and assess change control activities for potential cGMP impacts.
• Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and Pfizer quality standards.

Requirements

• B. Pharm, M. Pharm, or M. Sc degree.
• 6-7 years of experience in sterile injectable Quality Assurance, technology transfers, or validations.
• Solid understanding of current Good Manufacturing Practices (cGMP) and relevant GxP regulations.
• Strong critical thinking and proactive problem-solving skills.
• Ability to work effectively within individual and interdepartmental teams.
• Proficiency in Microsoft Excel and Word.

About the Company

Pfizer is a global leader in healthcare, dedicated to unearthing innovative therapies that transform millions of lives. We foster a culture of individual ownership and are looking for talented professionals to join our global community in making the world a healthier place.