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.