Head-Development Quality Assurance (DQA)

Please find below the JD for the Head – DQA position.Audit and review the quality management system (QMS) compliance of R&D and Pilot Plant. Share the findings to seniors and ensure compliances.Owner and management of stage gate process application. Co-ordinate with CFT and ensure the compliance of stage gate process of all new products launch.Owner and management of electronic lab notebook (ELN) for R&D function. Ensure all the lab experiments are logged in ELN. Review the ELN system and ensure compliance.Owner and management of Techpack management digital application (TMS).Review and finalization of technology transfer documents for product piloting and commercialization.Ensure confidentiality of R&D documents. Upload the TTDs on digital TMS application and control the documents access through digital application.Provide quality inputs to R&D scientists during product development stage for consistency in quality w.r.t. FTR and QbD prospective.Review, finalization and approval of manufacturing process SOPs,, Product stability data and COAs released from R&D.Review and approval of analytical method development, validation data and other analytical documents like specifications and STPs.Lead the analytical pilot team and DQA. Manage the routine activities of lab like planning, procurement, budgets, instrument AMC/CMC etc..Preparation and management customer audits, visits and ISO audits.

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