- Conducted in-process quality checks and line clearance activities during manufacturing and packaging operations to ensure cGMP compliance.
- Performed sampling at various stages of manufacturing and packaging as per approved procedures and specifications.
- Managed electronic batch records (EBR) through ProcessXE and created/maintained formats in eBPCR.
- Drafted, reviewed, and revised SOPs and quality documents using the QEDGE document management system.
- Compiled, analyzed, and trended data for Annual Product Quality Reviews (APQRs) to support product quality assessment and continuous improvement.
- Prepared Continued Process Verification (CPV) reports, including statistical trending of critical process parameters and quality attributes.
- Executed and reviewed Process Validation, Cleaning Validation, and Hold Time Studies in accordance with approved protocols and regulatory requirements.
- Reviewed and released batch manufacturing and packaging records for domestic and export markets, ensuring compliance with GMP and market-specific requirements.
- Coordinated with Production, Quality Control, Quality Assurance, and Regulatory Affairs teams for investigation, documentation, and batch disposition activities.