Manager / Senior Manager - Quality Control

Job Description: - Lead and manage the complete Quality Control laboratory operations. - Supervise QC testing of Raw Materials, Packaging Materials, In-Process Samples, Finished Products and Stability Samples . - Ensure analytical testing is performed as per approved specifications, STPs, pharmacopoeial and regulatory requirements . - Manage analytical instruments such as HPLC, GC, UV, FTIR, Dissolution, KF, pH Meter, TOC and other laboratory equipment. - Review and approve analytical results, COA, specifications, test methods and laboratory reports . - Ensure compliance with cGMP, GLP, WHO-GMP, SOPs and data integrity requirements . - Handle and review OOS, OOT, deviations, investigations, CAPA and change controls related to QC. - Manage stability studies including protocol preparation, sample analysis and trend evaluation. - Ensure proper calibration, qualification and preventive maintenance of QC instruments. - Coordinate with QA, Production, R&D, ADL, Engineering and Regulatory Affairs for quality-related activities. - Review analytical methods, method validation/verification, method transfer and related documentation. - Prepare the QC department for regulatory inspections and customer audits . - Ensure laboratory documentation complies with ALCOA+ data integrity principles . - Develop, train and evaluate QC personnel and maintain competency records. - Plan manpower, laboratory resources, chemicals, consumables and instrument requirements. - Monitor QC laboratory performance, turnaround time and adherence to testing schedules. - Drive continuous improvement, laboratory efficiency and compliance culture . - Participate in product development, technology transfer and troubleshooting activities where required. Preferred Experience - Strong experience in sterile / injectable pharmaceutical manufacturing . - Experience with SVP / LVP / PFS / powder for injection / speciality injectable products will be preferred. - Good knowledge of pharmacopoeias, GMP/GLP and regulatory expectations . - Experience in handling regulatory audits / customer audits will be an advantage. - Strong team leadership and analytical problem-solving skills.