Sr.Executive / Executive : M.Sc./ B.Sc. Chemistry with 3 - 8 year , must be familiar with cGMP requirements, Data Integrity, Document Cell, Batch release process, Trending APR shop floor Operation in API / Bulk Drug
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