Senior Officer

Glenmark Pharmaceuticals

Required skills

Website: glenmarkpharma.com
Job details:
Job Description

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.

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