Associate Manager - Quality Assurance

Responsibilities

• Evaluate and review commercial drug batches to ensure compliance with established specifications
• Manage New Product Introduction (NPI) projects and ensure zero-defect technology transfers for new products
• Provide quality support and review for scale-up, pilot bio batches, and exhibit batches to meet regulatory expectations
• Review and approve process validation protocols, cleaning validation, filter validation, and QRM reports
• Review optimization reports, technology transfer reports, analytical data sheets, and stability data
• Manage and approve investigations and change control activities to maintain compliance with configuration management policies
• Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as required
• Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide oversight of site documentation

Requirements

• B.Pharm, M.Pharm, or M.Sc degree
• 6 to 7 years of experience in sterile injectable technology transfers, Quality Assurance, or validation
• 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 discovering and developing 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.