Job Description

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: ₹15,000.00 - ₹21,000.00 per month

Benefits:

Provident Fund
Work Location: In person