Assistant Manager

4 weeks ago

Ankleshwar India Zentiva Full time

Job Description

Job Title: Sr. Executive / Assistant Manager Quality Assurance, Pharma

Educational Qualification

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

Experience

- 8 to 10 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

- 810 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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