ZTMP - QC Reviewer (Sikkim Unit II)

Name of the Company – Zydus Healthcare Limited

Industry – Pharmaceuticals

Website of the company - https://www.zyduslife.com/zyduslife/

Location –Sikkim Unit II

Position - Assistant Manager / Deputy Manager

Qualification – M.Sc./B.Sc./B. Pharma

Experience Required – Between 08 to 12 Years of Experience

Role – Reviewer

Experience / Exposure in:

• Must have worked in regulated plants having approvals of USFDA, MHRA. etc.
• Hands-on experience in handling and implementing cGMP (Current Good Manufacturing Practice) practices and Good Documentation Practices.

Job Description:

1. Responsible for reviewing laboratory records, including analytical data, logbooks, standardization, and calibration records generated during analyses.

2. Prepare and review GTPs, specifications, STPs, and SOPs required for the analysis of raw materials, in-process, and finished products.

3. Ensure online documentation and data integrity of raw data in accordance with current GDP guidelines.

4. Conduct laboratory investigations in cases of any OOS, OOT, OOC incidents, and non-compliance.

5. Handle change control, deviations, and CAPAs.

6. Troubleshoot analytical issues encountered during day-to-day analyses.

7. Participate in training sessions and update training records accordingly.

8. Coordinate with inter-departmental teams and outside laboratories as required.

9. Ensure adherence to GLP and laboratory safety practices.

10. Provide support for any additional assignments given by the department head or section head.