- Maintain and improve QMS in compliance with GMP and regulatory guidelines.
- Handle deviations, CAPA (Corrective and Preventive Actions), change controls, and incident reports.
- Ensure proper documentation practices across departments.
- Review batch manufacturing records (BMR) and batch packing records (BPR).
- Prepare and review SOPs (Standard Operating Procedures).
- Ensure data integrity and compliance with regulatory requirements (FDA, WHO, MHRA, etc.).
- Participate in process validation, cleaning validation, and equipment qualification (IQ, OQ, PQ).
- Ensure validation protocols and reports are properly executed and documented.
- Conduct internal audits and support external audits by regulatory authorities.
- Ensure readiness for inspections and address audit observations.
- Implement corrective actions for audit findings.
- Provide GMP and quality-related training to employees.
- Ensure training records are maintained and up to date
- Review quality control results and batch documentation.
- Perform risk assessment and implement mitigation strategies.
- Ensure compliance with quality risk management principles.
- Bachelor’s/Master’s degree in Pharmacy, Chemistry, Microbiology, or related field.
- Strong knowledge of GMP, GLP, and regulatory requirements.
- 1–3 years of experience in pharmaceutical QA
Pay: ₹20,000.00 - ₹25,000.00 per month
Work Location: In person