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Life Sciences For AQA Role at OrBion Pharmaceuticals Pvt Ltd
Company – OrBion pharmaceuticals
Job role – Analytical Quality Assurance (AQA) 1- 5 years of exp
Location – Chennai, Tamil Nadu
Interview Mode – Telephonic interview and direct interview for 2nd round
Experience – 1–5 years
Qualifications – M.Pharm / M.Sc / B.Pharm
1–3 years of proven experience in QA Documentation within a pharma or biotech setup.
Work Mode – On-site
Salary – Salary according to expertise and experience
Educational Qualification – B.Sc / M.Sc / B.Pharm / M.Pharm or any Life Science/Pharmacy background.
Job Summary:
The Analytical Quality Assurance professional will be responsible for ensuring compliance and integrity of analytical operations within the Quality Control laboratory. This role involves
monitoring day-to-day analytical activities, performing documentation review, ensuring adherence to cGMP practices, and supporting regulatory audit readiness. The candidate should be willing to work in night shifts and maintain high standards of data integrity and laboratory compliance.Quality Assurance Oversight
• Perform real-time monitoring of analytical operations across QC laboratories (wet chemistry, instrumentation, stability, RM/FP labs).
• Ensure adherence to cGMP, GLP, ALCOA+ principles, and internal SOP compliance.
• Conduct line clearance and verify readiness of analytical instruments before sample analysis.
• Review and approve analytical raw data, worksheets, logbooks, test records, and chromatographic data.
B. Documentation & Compliance
• Conduct QA review of analytical documents, including STPs, SOPs, protocols, and COAs.
• Ensure data accuracy, traceability, and integrity in documentation and electronic systems.
• Review instrument entries, audit trails, and ensure compliance with 21 CFR Part 11 and regulatory guidelines.
C. Deviations, OOS, OOT & CAPA Handling
• Support investigation of OOS (Out of Specification), OOT (Out of Trend), and deviations.
• Track CAPA implementation and effectiveness checks.
• Participate in root cause analysis and ensure timely closure of quality events.
Stages of the interview may include:
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Telephonic round
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Come down for the direct face-to-face





















