క్వాలిటీ అషూరెన్స్ ఎగ్జిక్యూటివ్

!!!We are hiring!!!

Job Title: Analytical QA Reviewer

Department: Quality Assurance

Location: Chennai

Reports To: QA Manager / Head – Quality Assurance

Share your resume: info@solvitall.in

Whatsapp: +919702554132

Qualifications:

- Master’s degree (M.Sc.) in Chemistry, Pharmaceutical Sciences, or a related field.

- Bachelor’s degree (B. Pharm) and Master’s degree (M. Pharm) are preferred.

Experience: 2 - 5 years of relevant experience in QA of pharmaceutical testing and analytical research and development (R&D)

Job Description:

1. The Analytical QA Reviewer is responsible for the thorough review and approval of analytical data generated from LC-MS/MS, GC-MS/MS, and ICP-MS/MS instruments used for impurity profiling and elemental analysis.

2. The role involves verifying raw data, chromatograms, spectra, and processed results to ensure accuracy, integrity, and compliance with approved analytical methods and specifications.

3. The position requires detailed review of analytical documents including test reports, Certificates of Analysis (COA), method development reports, and method validation protocol and reports.

4. The QA reviewer ensures all analytical activities comply with regulatory requirements such as GLP, ICH guidelines (Q2, Q3D), and data integrity principles (ALCOA+).

5. The role includes reviewing laboratory investigations such as Out of Specification (OOS), deviations, and incidents to confirm scientifically justified root cause conclusions.

6. The reviewer evaluates and approves Corrective and Preventive Actions (CAPA) to ensure effectiveness and prevent recurrence of analytical issues.

7. The position involves verifying that analytical methods are properly validated and that any method changes are appropriately controlled and documented.

8. The QA reviewer ensures that instruments such as LC-MS/MS, GC-MS/MS, and ICP-MS/MS are qualified, calibrated, and maintained as per regulatory and internal requirements.

9. The role requires ensuring compliance with data integrity regulations including 21 CFR Part 11, with proper control of electronic data and audit trails.

10. The reviewer supports internal audits, client audits, and regulatory inspections by providing accurate documentation and responding to audit queries.

11. The position involves close coordination with analytical R&D, quality control, and other departments to resolve technical and documentation-related queries.

12. The QA reviewer ensures timely review and release of analytical data to meet project timelines without compromising quality and compliance.

13. The role requires strong attention to detail, critical evaluation skills, and the ability to identify discrepancies or inconsistencies in analytical data.

14. The position contributes to continuous improvement by recommending enhancements in analytical procedures, documentation practices, and quality systems.

• It is a Full Time ల్యాబ్ సాంకేతిక నిపుణుడు job for candidates with 2 - 5 years of experience.