1.Review and approve of development protocol, reports (formulations, analytical, stability), Specifications and STPS, Process validations. Protocols. Cleaning validations and Analytical Method validations.
2.Implementation and monitor of change control system. Deviation management, CAPA and Risk Management.
3.Ensure Compliance with ICH guidelines.
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📌 FDQA Professional (Hyderabad)
🏢 Promea Therapeutics
📍 Hyderabad
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