We are looking for a agile and experienced Quality Control (QC) Manager to lead our QC operations for Sterile and Injectable manufacturing facilities. The ideal candidate will have 10 to 12 years of hands-on pharmaceutical QC experience, ensuring strict compliance with cGMP, GLP, and international regulatory standards (USFDA, MHRA, EU-GMP, WHO).

Key Responsibilities

1. Laboratory Operations: Manage daily chemical and microbiological testing activities for raw materials, in-process samples, finished injectable products, and stability batches.
2. Regulatory & Audit Compliance: Lead regulatory inspections and client audits (USFDA, EU-GMP, WHO) while ensuring 100% adherence to cGMP, GLP, and Data Integrity (ALCOA+) guidelines.
3. Method Validation & Transfer: Oversee analytical method validation (AMV), method verification, and analytical method transfers (AMT) across sites.
4.



Quality Management Systems (QMS): Handle and review Out-of-Specification (OOS), Out-of-Trend (OOT), laboratory incidents, deviations, CAPA, and change controls within strict timelines.
5. Instrument & Calibration Management: Ensure timely qualification (IQ/OQ/PQ), calibration, and preventive maintenance of sophisticated instruments like HPLC, GC, UV-Vis, KF Titrator, and TOC analyzers.
6. Team Leadership & Training:
7. Supervise, mentor, and train a team of QC chemists and microbiologists to improve lab efficiency and reduce testing turnaround time (TAT).

M.Sc. (Chemistry / Analytical Chemistry / Microbiology) or B.Pharm / M.Pharm from a recognized university.

📌 QC Manager (India)
🏢 ishwer enterprises
📍 India