Quality Assurance Executive
2 weeks ago
**Key Responsibilities**:
- Review and ensure compliance with cGMP, WHO-GMP, and regulatory guidelines.
- Prepare, review, and control SOPs, BMRs, BPRs, and validation protocols.
- Conduct in-process checks, documentation audits, and product sampling.
- Participate in internal audits, self-inspections, and coordinate during external audits.
- Monitor deviations, change controls, CAPA, and OOS investigations.
- Ensure proper documentation practices and batch release processes.
- Liaise with cross-functional departments (QC, Production, Regulatory Affairs) to ensure quality compliance.
- Maintain a document control system and ensure traceability.
- Required Skills and Qualifications:
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, or Life Sciences.
- 2-3 years of experience in QA within the pharmaceutical or API formulation industry.
- Good knowledge of regulatory guidelines (WHO, ICH, USFDA).
- Proficiency in handling quality documentation and GMP audits.
- Strong communication and analytical skills.
- Ability to work independently and as part of a team.
Pay: Up to ₹30,000.00 per month
Schedule:
- Day shift
Work Location: In person
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