
Quality Assurance
2 days ago
Job Summary
We are looking for a detail-oriented and system-driven Quality Assurance (QA) professional to ensure organization-wide compliance with GMP, GLP, regulatory standards, and internal SOPs. This role involves cross-functional coordination with departments such as Production, QC, R&D, Raw Materials, Finished Goods, Maintenance, and Projects/Engineering to maintain quality systems and ensure audit readiness.
Key Responsibilities
1. Quality Control (QC)
- Review and approval of test methods, specifications, and SOPs.
- Conduct audits focusing on data integrity and documentation practices.
- Investigate and manage Out of Specification (OOS) results and CAPAs.
- Ensure calibration and qualification of laboratory instruments.
2. Production
- Approve Batch Manufacturing Records (BMRs), process-related SOPs, and cleaning validation protocols.
- Monitor adherence to cGMP during manufacturing operations.
- Manage deviations, change controls, and the batch release process.
3. Research & Development (R&D)
- Review and approve method validations and technology transfers.
- Ensure GLP compliance and documentation traceability.
- Audit R&D processes for data integrity and regulatory readiness.
4. Raw Material (RM)
- Approve material specifications and sampling plans.
- Ensure proper vendor qualification and traceability of materials.
- Authorize release or rejection of raw materials based on QC test results.
5. Finished Goods (FG)
- Verify packaging and labeling compliance.
- Approve finished product release post complete batch record review.
- Ensure storage and dispatch practices adhere to GMP standards.
6. Maintenance
- Ensure maintenance records (preventive and breakdown) meet GMP compliance.
- Review the impact of breakdowns on quality-critical areas.
- Approve equipment qualifications (IQ/OQ/PQ) and oversee calibration schedules.
7. Projects / Engineering
- Participate in Design Qualification (DQ) processes.
- Review and approve equipment and facility validations (IQ/OQ/PQ).
- Ensure that utility systems (HVAC, water, cleanrooms) meet GMP requirements.
- Manage change controls and conduct risk assessments during facility upgrades.
- Conduct audits focusing on data integrity and documentation practices.
- Investigate and manage Out of Specification (OOS) results and CAPAs.
- Ensure calibration and qualification of laboratory instruments.
Requirements
- Bachelor's/Master's degree in Pharmacy, Chemistry, Biotechnology, or related field.
- 1–5 years of QA experience in a pharmaceutical or biotech environment.
- Strong knowledge of GMP, GLP, regulatory guidelines, and quality systems.
- Experience in audits, documentation review, and quality investigations.
Preferred Skills
- Good communication and coordination abilities.
- Attention to detail and strong documentation skills.
- Working knowledge of QMS software/tools is a plus.
Job Types: Full-time, Permanent
Pay: ₹15, ₹21,000.00 per month
Benefits:
- Provident Fund
Work Location: In person
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