Knowledge of ICH and WHO guidelinesHand on experience of dossier preparation in CTD, ECD, MHRA formatsLiaison with DRAP personals & queriesExposure of product registration in Europ, Latin America etcANalytical approach of stability studies of dif

Ideal candidate must be capable enough to develop new formulations, conduct trial batches, and perform testing. Able to operate HPLC, UV, TOC Analyzer, Stability Chamber etc.

Consistently execute test cases (manual and/or automated) and analyze results in a timely manner.Evaluate product code according to specifications.Generate logs to document testing phases and defects.Effectively report bugs an

Implements Operational manuals & production plans.Checks the availability of adequate raw and packing materials, utilities and machine size parts.Executes the weekly and monthly production plans according to the schedule.E

Ensure that lab cleanliness and safety standards are maintained.Provide desire data necessary for regulatory submissions.Evaluate quality of materials or products.Validations or transfers of analytical methods in accordance wi