06 Aug
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Acme Formulation
|
Nalagarh
06 Aug
Acme Formulation
Nalagarh
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