Acme Formulation
Website:
acmeformulation.com
Job details:
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 efficient 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.
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