Lab QA Reviewer

Experience: 08 to 14 years

Location: Zhl - Sikkim, Gangtok, Sikkim, India

Skills: Document Management, Control Sample Handling, Quality Documentation, Quality Issue Reporting, Data Integrity Compliance, QC Data Verification, Standards & Equipment Management

Company Overview
Zydus Healthcare Limited is a leading player in the Pharmaceuticals industry, dedicated to providing high-quality healthcare solutions. For more information, visit our website at https://www.zyduslife.com/zyduslife/.

Position Overview
The Lab QA Reviewer will be responsible for ensuring the quality and compliance of laboratory processes and documentation. This role involves managing various quality assurance activities to maintain high standards in the pharmaceutical production setting.

Duties and Responsibilities
1. Document Management: Archive, retrieve, retain, and securely destroy master and obsolete documents with proper indexing and authorization.
2. Control Sample Handling: Manage storage, issuance (with QA Head approval), periodic review, and authorized destruction of control samples.
3. Stability Monitoring:



Monitor stability data and coordinate the review and circulation of reports to relevant departments (Corporate QA, PTC, RA).
4. Quality Documentation: Prepare, review, and control quality-related documents and ensure compliance with the document management system.
5. Quality Issue Reporting: Escalate any quality-related issues to Management promptly.
6. Data Integrity Compliance: Implement data integrity policies and report any breaches to Management and the Data Integrity Compliance Head.
7. Analytical Review: Review specifications, test procedures, and inspection plans for various materials and products including raw, in-process, and finished goods.
8. QC Data Verification: Cross-verify QC-submitted data against raw data, logbooks, and LIMS/SAP entries.
9. Standards & Equipment Management: Ensure proper management of working/reference standards, impurities, and chromatography columns.
10. Audit Trail & Batch Review: Review audit trails and electronic data for compliance, and support batch release decisions based on verified data.

📌 Lab QA Reviewer (Gangtok)
🏢 Zydus Lifesciences
📍 Gangtok