08 Sep
|
Zydus Group
|
Ankleshwar
08 Sep
Zydus Group
Ankleshwar
Division
- ANKLESHWAR QA -U1
- Job posted on
- Feb 23, 2026
- Employee Type
- P-P8-Probationer-HO Executive
- Experience range (Years)
- 0 - 0
- Ensure compliance with GMP, safety norms, company policies, and Positive Laboratory Practices (GLP).
- Review and approve analytical reports for intermediates, APIs, drug substances, stability studies, and instrument calibration.
- Oversee Unit‑II stability and API reports, working/reference standards, and Certificates of Analysis (COA).
- Manage laboratory incidents, out‑of‑calibration investigations, and controlled QC documentation.
- Review continuous process verification data, audit trails in laboratory software, and user access privileges.
- Conduct pharmacopoeia evaluations, specifications,
and standard testing procedures.
- Coordinate documentation for Drug Master File (DMF) filings.
- Validate laboratory instruments, equipment, and software systems.
- Support technology transfer, change management, and risk assessment activities.
- Review trend analysis reports, stability summaries, miscellaneous protocols, and training evaluations.
- Initiate, track, and close Corrective and Preventive Actions (CAPA) in Trackwise.
- Collaborate with cross‑functional teams to ensure regulatory readiness and continuous improvement.
📌 QA of Qc (Ankleshwar)
🏢 Zydus Group
📍 Ankleshwar