Description

Key Responsibilities 1. Analytical Testing Perform routine analysis of raw materials, intermediates, APIs, finished products, and in-process samples. Operate analytical instruments such as: HPLC GC UV-Visible Spectrophotometer FTIR Karl Fischer pH meter Analytical balance Other laboratory instruments as applicable Perform testing according to approved specifications, analytical methods, and pharmacopoeial requirements. Calculate, record, and review analytical results accurately. 2. Sample Management Receive and verify QC samples as per approved procedures. Ensure proper sample identification, labeling, storage, and traceability. Perform sample preparation according to approved methods. Ensure testing is completed within established timelines. 3. Documentation & Data Integrity Maintain laboratory notebooks, worksheets, logbooks, chromatograms, and analytical records. Follow Good Documentation Practices and ALCOA+ data-integrity principles. Ensure raw data and analytical results are complete, accurate, attributable, and traceable. Report documentation errors or data discrepancies immediately. 4. OOS / OOT / Deviation Support Immediately report OOS, OOT, atypical results, instrument failures, and laboratory incidents. Support laboratory investigations and Root Cause Analysis. Provide required raw data and technical information for investigations. Support implementation of CAPA and corrective actions. 5. Instrument Management Operate laboratory instruments according to approved SOPs. Perform routine instrument checks and system suitability. Maintain instrument usage and logbook records. Report equipment breakdowns and abnormalities. Support calibration, qualification, and preventive-maintenance activities. 6. Reagents & Standards Prepare reagents, solutions, mobile phases, and volumetric solutions as per approved procedures. Ensure proper labeling and storage of reagents and solutions. Maintain records for preparation, standardization, and expiry.



Monitor availability and expiry of reference standards and laboratory chemicals. 7. Stability Testing Perform testing of stability samples according to approved protocols and schedules. Maintain stability sample and analytical records. Report atypical or unexpected stability results promptly. Support preparation and review of stability data. 8. GMP / GLP Compliance Follow GMP, GLP, SOPs, specifications, test methods, and safety procedures. Maintain laboratory housekeeping and 5S. Support internal, customer, and regulatory audits. Participate in audit preparation and implementation of corrective actions. 9. Safety & EHS Follow laboratory safety procedures and chemical-handling requirements. Wear appropriate PPE. Handle solvents, reagents, compressed gases, and laboratory chemicals safely. Follow laboratory waste-disposal procedures. Report incidents, near misses, and unsafe conditions. 10. Continuous Improvement Participate in laboratory productivity and efficiency-improvement initiatives. Support analytical method improvements and troubleshooting. Participate in Kaizen, 5S, and other continuous-improvement activities. Suggest improvements to laboratory processes and documentation. Qualifications M.Sc. in Chemistry / Analytical Chemistry / Pharmaceutical Chemistry preferred. B.Sc./B.Pharm with relevant QC experience may be considered. 2–6 years of experience in API/pharmaceutical QC. Valuable hands-on experience with HPLC and/or GC is preferred. Key Skills HPLC / GC analysis UV / FTIR / KF Wet chemistry Analytical method execution Sample preparation OOS/OOT awareness GMP / GLP ALCOA+ and data integrity Good Documentation Practices Instrument handling Laboratory safety Analytical troubleshooting Key KPIs Timely completion of analytical testing Accuracy of analytical results Right-first-time testing Documentation accuracy OOS/OOT reporting and investigation support Instrument utilization and compliance Stability testing completion GMP/GLP compliance Data-integrity compliance

📌 Apprentice (Mumbai)
🏢 Cadila Pharmaceuticals
📍 Mumbai