QA – QMS (Parenteral Operations)-Vadodara, Gujarat, India
- Position: Executive / Sr. Executive – Quality Assurance (QMS)
- Experience: 2–8 years
- Qualification: B.Pharm / M.Pharm / B.Sc / M.Sc
- Industry: Sterile/Parenteral/Injectable Manufacturing
Key Responsibilities
Manage QMS elements: Deviations, CAPA, Change Controls, Complaints, Risk Assessments.
Review and approve batch records, sterilization logs, and EM reports.
Support aseptic operations, media fills, gowning compliance, and contamination control.
Participate in internal, customer, and regulatory audits (USFDA, EU, WHO).
Review and maintain SOPs, protocols, and GMP documentation (ALCOA+).
Coordinate investigations and drive timely closure of QMS records.
Required Skills
- Strong understanding of parenteral/sterile manufacturing.
- Hands‑on QMS experience (Deviation, CAPA, CC).
- Knowledge of cGMP, Annex 1, ICH Q9/Q10.
- Good analytical and documentation skills.
Experience with electronic QMS tools (TrackWise, Veeva) preferred.
Interested candidate can share cv on : Vishal.Raval@zyduslife.com
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