Role & responsibilities
- Lead and manage the overall Quality Control function for General Block and Hormone Block.
- Ensure timely sampling, testing, review, and release of RM, PM, in-process, bulk, finished products, stability, microbiological, and validation samples.
- Ensure compliance with cGMP, cGLP, Data Integrity, and 21 CFR Part 11 requirements.
- Oversee LIMS operations, review specifications, analytical methods, and laboratory documentation.
- Drive timely closure of OOS, OOT, Deviations, Incidents, and CAPA investigations.
- Coordinate with Production, Planning, Dispatch, R&D;, customers, and external laboratories for timely analytical support and batch release.
- Ensure laboratory readiness for regulatory and customer audits.
- Review quality risk assessments and ensure effective implementation of quality systems.




- Optimize laboratory resources, equipment, and manpower for productive operations.
- Ensure calibration, qualification, and preventive maintenance of laboratory instruments.
- Develop team capability through regular technical and GMP training.
- Drive continuous improvement initiatives to enhance laboratory compliance, efficiency, and productivity.

Qualification

M.Sc. / M.Pharm. in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, or a related discipline.

Experience

18-25 years in Quality Control within a USFDA/EU GMP-approved pharmaceutical manufacturing facility, including experience leading the QC function.

📌 Head & DGM Quality Control (Nalagarh)
🏢 Acme Formulation
📍 Nalagarh