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
- Solid 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 ex

📌 Manager / Senior Manager - Quality Control (Vadodara)
🏢 SDP HR Solution
📍 Vadodara