Senior Executive Job in CPL Pharmaceuticals Private Limited at Mumbai

5–8 years of relevant experience in Quality Control, preferably in API/pharmaceutical manufacturing. Job Overview Responsible for planning, supervising, and executing quality-control activities for raw materials, intermediates, finished APIs, in-process samples, and stability samples. The role ensures laboratory activities comply with cGMP, GLP, SOPs, data-integrity requirements, and applicable regulatory standards. Key Responsibilities Plan and supervise routine QC testing of raw materials, intermediates, APIs, solvents, and finished products. Perform/review analysis using techniques such as: HPLC GC UV-Visible spectroscopy FTIR Karl Fischer pH / conductivity Titration and wet-chemistry methods Other applicable analytical techniques Review analytical data, calculations, chromatograms, spectra, and laboratory records. Ensure testing is performed according to approved specifications, STPs, analytical methods, and SOPs. Review and approve analytical worksheets, test reports, COAs, and laboratory documentation as per authorization. Investigate and support OOS, OOT, deviations, and laboratory incidents. Participate in root-cause investigations and implementation of CAPA. Ensure proper handling, calibration, and maintenance of laboratory instruments. Coordinate instrument qualification, calibration, and preventive maintenance activities. Review and execute analytical method validation/verification/transfer activities. Manage stability study testing and ensure samples are analyzed according to approved protocols and schedules. Ensure proper sample management, storage, retention, and disposal. Maintain laboratory housekeeping and ensure compliance with GLP/GMP requirements. Ensure adherence to ALCOA+ data-integrity principles and electronic data controls. Train QC analysts on analytical procedures, instruments, SOPs, GMP, and safety. Coordinate with Production, QA, R&D, and other departments for analytical requirements. Support internal, customer, regulatory, and external audits. Prepare and provide QC documentation and analytical data during inspections and audits. Identify opportunities for improving laboratory efficiency, analytical reliability, and turnaround time. Regulatory / GMP Knowledge Strong knowledge of cGMP and GLP requirements. Understanding of ICH guidelines, particularly relevant analytical and stability requirements. Knowledge of ALCOA+ data integrity principles. Familiarity with OOS/OOT investigation procedures. Understanding of deviation, CAPA, change control, and laboratory incident management. Knowledge of analytical method validation and verification. Experience with audit and regulatory inspection requirements. Technical Skills Hands-on experience with HPLC and GC. Knowledge of chromatographic data systems such as Empower or equivalent. Experience with analytical instruments and laboratory software. Good understanding of analytical method troubleshooting. Knowledge of laboratory investigations and root-cause analysis. Working knowledge of LIMS is an advantage. Good documentation and report-writing skills. Qualification M.Sc. Chemistry / M.Pharm / B.Pharm / equivalent qualification from a recognized institution. Key Competencies Analytical testing and troubleshooting HPLC/GC expertise Data review OOS/OOT investigation GMP/GLP compliance Data integrity Team supervision Documentation Problem-solving Cross-functional coordination Key Performance Indicators (KPIs) Testing turnaround time Analytical accuracy and reliability OOS/OOT investigation effectiveness Compliance with GMP/GLP requirements Data-integrity compliance On-time stability testing Instrument calibration/qualification compliance Audit/inspection readiness