KAMALJITSINH CHAVDA

• To perform IPQA activities:
• Review master batch record, batch repacking record & process flow diagram
• Ensuring archival of the product change over cleaning record, master batch record, batch repacking record & process flow diagram
• Issuance of BMR/PCCR
• Certify line clearance of equipment
• To check and verify process control parameters during manufacturing.
• Performance of the physical verification of the reserve sample as per frequency
• To maintain all the activities of the reserve sample through LIMs software.
• To verify the disruption of the seals, collection of composite sample by external waste disposal agency, removal of labels & loading of the batches into vehicles.
• To perform sampling activity as per sampling details
• To verify the equipment/area for the cleanliness & completeness of the documents.
• SAP activities:
• Process order approval
• Stock overview
• Approval for sample labels
• To transfer the subjected disposed off batches from restricted/block stock to unrestricted stock

• Experienced in Process and Cleaning Validation, including protocol preparation, execution, sampling, data review, and report completion in compliance with GMP.
• Hands-on experience in Change Control Management from initiation to closure as per SOPs.
• Prepared and reviewed BPCR/BMR ensuring adherence to approved master documents and regulatory requirements.
• Involved in GMP training activities, including coordination, record maintenance, and personnel qualification.
• Strong knowledge of GMP documentation, SOP compliance, data integrity, and cross-functional coordination with Production, QA, and QC.