!!!We are hiring!!!

Job Title: QA executive - Analytical R&D;

Department: Quality Assurance

Location: Chennai

Reports To: QA Manager / Head – Quality Assurance

Send your resume : [email protected]

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;)

:

- 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.
- The role involves verifying raw data, chromatograms, spectra, and processed results to ensure accuracy, integrity, and compliance with approved analytical methods and specifications.
- The position requires detailed review of analytical documents including test reports, Certificates of Analysis (COA), method development reports, and method validation protocol and reports.
- The QA reviewer ensures all analytical activities comply with regulatory requirements such as GLP, ICH guidelines (Q2, Q3D), and data integrity principles (ALCOA ).
- The role includes reviewing laboratory investigations such as Out of Specification (OOS), deviations, and incidents to confirm scientifically justified root cause conclusions.




- The reviewer evaluates and approves Corrective and Preventive Actions (CAPA) to ensure effectiveness and prevent recurrence of analytical issues.
- The position involves verifying that analytical methods are properly validated and that any method changes are appropriately controlled and documented.
- 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.
- The role requires ensuring compliance with data integrity regulations including 21 CFR Part 11, with proper control of electronic data and audit trails.
- The reviewer supports internal audits, client audits, and regulatory inspections by providing accurate documentation and responding to audit queries.
- The position involves close coordination with analytical R&D;, quality control, and other departments to resolve technical and documentation-related queries.
- The QA reviewer ensures timely review and release of analytical data to meet project timelines without compromising quality and compliance.
- The role requires solid attention to detail, critical evaluation skills, and the ability to identify discrepancies or inconsistencies in analytical data.
- The position contributes to continuous improvement by recommending enhancements in analytical procedures, documentation practices, and quality systems.

Work Location: In person

Pay: ₹250,000.00 - ₹400,000.00 per year

Work Location: In person

📌 QA Executive - Analytical R&D - Only Experienced (Chennai)
🏢 Solvitall Research Labs Private
📍 Chennai