Manager QA Tech Transfer

Role & responsibilities

• Review new product information from R&D, including manufacturing process, testing methods, and packaging details.
• Lead technology transfer activities, ensuring products can be manufactured successfully at production sites.
• Evaluate manufacturing facilities and equipment to confirm they are suitable for producing the products.
• Participate in process validation to ensure the manufacturing process consistently produces quality products.
• Manage quality risks and investigate product failures, deviations, complaints, and non-conformances.
• Ensure Quality Management Systems (QMS) such as Change Control, CAPA, Deviations, OOS, Training, and Complaint Handling are properly followed.
• Review and approve quality documents like Master Formula Records, Batch Manufacturing Records, validation protocols, and reports.
• Coordinate with multiple teams including R&D, Production, Vendors, Laboratories, and Contract Manufacturing Sites to ensure compliance and smooth execution.
• Lead and manage QA teams, monitor performance, and escalate critical issues to management when needed.

Preferred candidate profile

• 17-22 years of experience in Quality Assurance and Manufacturing.
• Strong knowledge of pharmaceutical manufacturing processes (solid oral, liquids, powders, semisolids).
• Experience in GMP compliance, process validation, technology transfer, and quality systems.
• Team management experience and willingness to travel extensively