Executive - Quality Assurance, Pharma

17 hours ago

Ankleshwar, India Zentiva Group, a.s. Full time

Job Title: Executive - Quality Assurance, Pharma

Educational Qualification
- B. Pharm / M. Pharm from a reputed university

Experience
- 3 to 6 years of similar experience in a regulatory-approved OSD manufacturing large unit.

Job Responsibilities & Accountabilities:
We are looking for an experienced QA professional to join our team and lead Deviation & Complaint Investigations, along with core QMS activities.

Key Responsibilities:

- Lead deviation and market complaint investigations, with timely CAPA execution
- Ensure effective implementation and tracking of CAPAs from deviations & complaints
- Review Batch Manufacturing & Packing Records, APQR, and SOPs
- Manage Change Controls, Validations/Qualifications, and QMS documentation
- Conduct regulatory gap assessments and support compliance plan execution
- Coordinate GMP training, documentation control, and audit readiness

What We’re Looking For:

- 3 to 6 years of QA experience in pharmaceutical manufacturing (formulations)
- Strong understanding of cGMP, investigation tools, and regulatory expectations (USFDA, MHRA)
- Skilled in QMS systems.
- Excellent documentation, analytical, and coordination skills

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