Walk-in for QA, Prodn, QC , Process Engg 18th March 2016 @ Cadila Healthcare Limited - Akleshwar
Key Responsibilities are mentioned as below:
QUALITY ASSURANCE : Sr.Executive / Executive : M.Sc./ B.Sc Chemistry with 4 - 8 year , must be familiar with cGMP requirements, Data Integrity, Document Cell, Batch release process, Trending APR shop floor Operation in API / Bulk Drug
Manufacturing.
a) Data Integrity - Responsible to review of HPLC and GC , QC Sop Compliances, Investigation activities , OOS and OOT and quality control instruments.
b) Document Cell -Review of documents before DMF submissions, distribution / Issuance of BMRs, Master Formulae, SOPs and Formats to the respective departments and controlling all master documents.
c) Batch Release - Knowledge of ICH guidelines and should review of BMRs and Validation documents and to give usage decision and dispatch of all APIs and salable intermediates in LIMS and SAP.
d) Technology transfer documents - Review R&D process & TTD, evaluation of CPP & CQA and comparison with batch record , review of master batch record also review of specification and STP of API, Intermediate, RM, In-process.
e) Trending and APR - Knowledge of Market complaint, Deviation, Incident, Change control for trending of Systems, Review of Master SOPs, BMRs, PCRs, validation Protocols and reports and Annual Review reports.
PRODUCTION : Sr.Executive / Executive: Diploma /B.E / B.TECH (chemical) M.Sc./ B.Sc. (Chemistry) with 4 to 7 years of experience and relevant exposure in API / Bulk Drug Manufacturing. Should also have knowledge of GMP documentation. Must be familiar with cGMP requirements.
QUALITY CONTROL : Sr.Executive / Executive : M.Sc /B.Sc (Chemistry) with 4 - 8 years of hands on experience and relevant exposure in handling instruments like HPLC, GC, UV , wet lab and chemical analysis of Raw Material . Must be familiar with cGMP requirements. Shop floor Operation in API / Bulk Drug Manufacturing.
Process Engineering : Executive / Sr.Executive: B.E / B.TECH (chemical) with 4 to 6 years of experience and relevant exposure in API / Bulk Drug Manufacturing. Design of equipment, piping & facility. Solvent recovery. Heat & Mass balance. Capacity debottlenecking.
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