05 Aug
|
Zydus Lifesciences
|
Ahmedabad
05 Aug
Zydus Lifesciences
Ahmedabad
Lab QA Analyst
Experience: 3 to 5 years
Location: R&D; – ZRC|Fill & Finish, Ahmedabad, Gujarat, India
Skills: HPLC, LC-MS, UV, IR, Titration, Audit Trail, 21 CFR Part 11, Peptide Product Tests, QC Methods, Method Validation Protocol, Standard Test Procedure, Continued Process Verification
Company Overview
Group Company: Zydus Lifesciences Ltd
Designation
Executive/ Sr. Executive
Department
Quality Assurance (Lab QA)
Office Location
Unit 9 Fill & Finish
Category
Staff
Field specialization
Lab Quality Assurance
Degree
B. Pharm/ M Pharm/ BSC/MSC
Job Description
1. Data Review
- check chromatographic data (hplc, lc‑ms).
- check non‑chromatographic data (uv, ir, titration).
- confirm raw data is correct and complete.
2. Audit trail
- Review data audit trail (entries, edits, deletes)
- Review system audit trail (logs, user actions, 21 cfr part 11)
3. Product Focus
- Handle and check peptide product tests
- Review peptide qc methods and reports
4. Document Review
- Check method validation protocol
- Check method validation report
- Check product spec
- Check stp (standard test procedure)
- Check cpv (continued process verification) report
Reporting Team
Reporting Designation
Senior Manager
Reporting Department
Quality Assurance
📌 Lab QA Analyst (Ahmedabad)
🏢 Zydus Lifesciences
📍 Ahmedabad