Quality Assurance

4 days ago

Panvel, Maharashtra, India Sisco Research Laboratories Pvt. Ltd. Full time ₹ 1,89,000 - ₹ 2,52,000 per year

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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