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.
