Job Description

Job Title:

Quality Assurance Executive - Analytical Review

Department:

Quality Assurance

Location:

Nandesari,Vadodara

Reporting To:

Manager - Quality Assurance

Job Purpose:

To ensure compliance with regulatory standards by reviewing analytical specifications, method validation protocols, audit trails, and investigating laboratory incidents and deviations. The role supports data integrity, GMP compliance, and continuous improvement in laboratory operations.

Key Responsibilities:1. Specification Review

Review and approve analytical specifications for raw materials, intermediates, and finished products. Ensure specifications align with pharmacopeial standards and regulatory filings.

2. Method Validation

Review method validation protocols and reports for analytical methods (e.g., HPLC, GC, UV). Ensure validation parameters (accuracy, precision, specificity, robustness) meet regulatory expectations. Coordinate with QC and R&D for method transfer and verification.

3. Audit Trail Review

Conduct periodic and event-based audit trail reviews of computerized systems (e.g., Empower, Chromeleon). Ensure data integrity and compliance with 21 CFR Part 11 and EU GMP Annex 11. Document findings and escalate discrepancies to QA management. [pharmaguid...ines.co.uk]

4. Lab Incidents & Deviations

Investigate laboratory incidents, OOS (Out of Specification), and OOT (Out of Trend) results. Perform root cause analysis and recommend CAPAs. Ensure timely closure of deviations and documentation in QMS.

5. Documentation & Compliance

Maintain records of reviews, investigations, and approvals. Ensure compliance with internal SOPs, GMP, and regulatory guidelines. Support internal and external audits (e.g., USFDA, WHO, EU).

Qualifications & Experience:

B.Pharm / M.Pharm / M.Sc. in Chemistry or related field. 3-6 years of experience in QA/QC in a regulated pharmaceutical environment. Hands-on experience with analytical instruments and software. Knowledge of regulatory guidelines (ICH, FDA, WHO, EU GMP).
Job Types: Full-time, Permanent

Pay: ₹556,901.17 - ₹973,785.18 per year

Benefits:

Food provided Health insurance Provident Fund
Work Location: In person