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
Robust experience in sterile / injectable pharmaceutical manufacturing.
Experience with SVP / LVP / PFS / powder for injection / speciality injectable products will be preferred.
Valuable knowledge of pharmacopoeias, GMP/GLP and regulatory expectations.
Experience in handling regulatory audits / customer audits will be an advantage.
Robust team leadership and analytical problem-solving skills.

📌 Manager / Senior Manager Quality Control Vadodara
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📍 Vadodara