Executive / Sr.executive - Quality Assurance at API Ankleshwar
Cadila Healthcare Limited - AkleshwarEXPEREINCE ;- 2 - 7 yrs
Executive / Sr.Executive- Quality Assurance at API Ankleshwar
Here is a chance to join Zydus at our API Manufacturing Multi Product Plant located at Ankleshwar as.
Key Responsibilities are mentioned as below:
QUALITY ASSURANCE : Sr.Executive / Executive : M.Sc./ B.Sc Chemistry with 2-8 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 BMR;s 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 and issuance TTD to plant , 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, Trial batch reports, validation Protocols and reports and Annual Review reports.
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 BMR;s 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 and issuance TTD to plant , 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, Trial batch reports, validation Protocols and reports and Annual Review reports.
Contact No of HR representative: 02646-660408 / 660507
Candidates having experience of working in regulatory approved plants and possesses sound knowledge of documentation, cGMP and SAP will be preferred.
Please mention the position applying for on the top of envelope or subject in case of e-mail.
Preference will be given to candidates having API - Pharmaceutical Industries experience.
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