Minimum experience required in this position:
Preparing and reviewing Site Master File, Validation master plan, Master Batch Records, Departmental Manual, and Data Integrity Policy.
Executing and compiling equipment qualification, HVAC qualification, facility qualification, temperature mapping of areas.
Performing cleaning validation, process validation and Hold time study of drug products.
Preparing, Reviewing & Executing Water system and Compressed air protocol.
Ensuring adherence to quality standards & maintaining all the related documents; conducting inspections at various stages to ensure safety & quality specifications are met without any slippages.
Steering the implementation of cGMP for all operational activities.
Conducting audits and ensuring compliance and audit readiness; reviewing analytical reports.
Imparting training, conducting online on job as well as classroom trainings for cGMP, cGDP to support subordinates.
Participating in Internal Audits to ensure quality in other departments like Production, Warehouse, Engineering & QCand so on.
Addressing market complaints, deviation, CAPA, and change management systems.
Reviewing and Finalizing Artwork and Specification for Printed Packaging Materials.
Checking and preparing all the Dimensions of Art work and Send it to Pack Pilot for approval.
Participating in PLC/CSV validation activities.
Reviewing of Batch Manufacturing Records, Batch Packing Records and Bill of material
Preparing and reviewing of Annual product Quality Review.
Reviewing Instructions, Packaging configurations, Artwork, Shade cards, Specimen printed packing material, Specifications, Standard Test Procedures, Record of Analysis, Analysis Report, General Analytical Method and Stability Protocols.
Performing sampling of Process validation Protocol, Hold time study protocol.