Roles & Responsibilities:
- Ensure compliance with cGMP, GDP, SOPs, and regulatory requirements.
- Perform IPQA activities during dispensing, granulation, compression, coating, encapsulation, and packing.
- Conduct line clearance before batch start-up and after batch completion.
- Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and other GMP documents.
- Monitor in-process quality checks and verify critical process parameters.
- Handle deviations, change controls, CAPA, and incident investigations.
- Perform QA review and batch release activities.
- Conduct qualification and validation activities (Process Validation, Cleaning Validation, Equipment Qualification).
- Monitor environmental conditions and GMP compliance in manufacturing areas.
- Participate in internal audits,
self-inspections, and regulatory audits.
- Coordinate with Production, QC, Engineering, Warehouse, and Regulatory Affairs.
- Ensure proper documentation, data integrity, and compliance with quality systems.
Key Skills
- cGMP & GDP Compliance
- IPQA Activities
- Line Clearance
- BMR/BPR Review
- SOP Preparation & Review
- Deviation, CAPA & Change Control
- Process & Cleaning Validation
- Equipment Qualification
- Batch Release
- Documentation & Data Integrity
- Audit Readiness
- Problem Solving
- Attention to Detail
- Teamwork & Communication