Role & responsibilities
- Ensure compliance with cGMP, SOPs, and quality procedures.
- Review Batch Manufacturing Records (BMR) and related documents.
- Perform line clearance and in-process quality checks.
- Handle deviations, CAPA, Change Control, and incident investigations.
- Review and update SOPs and quality documents.
- Support process validation, cleaning validation, and qualification activities.
- Conduct GMP training and internal audits.
- Coordinate with Production, QC, Warehouse, and Engineering for quality-related activities.
- Participate in customer and regulatory audits (USFDA, CDSCO, etc.).
- Ensure proper documentation and timely closure of quality activities.
Preferred candidate profile
- Knowledge of cGMP and Quality Systems
- Positive documentation and communication skills
- Familiarity with regulatory requirements
- Proficiency in MS Office