Research And Development Associate

Job Description

Purpose of the Role: Lead the DQA department to implement CGMP rules and regulations in Research & Development. Qualification :- M.Sc. in Chemistry or relevant Science stream Minimum 4 years. Preferred in Pharmaceutical industries Key Responsibility Areas 1.Review the Lab validation Protocol and Report of CRD. 2.Review of Process Development report for DMF filing. 3.Review of Specification and STP of Key Raw Material, In-Process, Intermediate stage and Finished Product. 4.Review of Method Development Report, Method Validation Protocol/Report, Method Transfer Protocol of ADL. 5.Review the stability protocol and Report. 6.Preparation of SOP, Formats / Annexures, Log books, and ensure RA and GLP Compliance. 7.Interaction and Communicate with R&D, ARD, QA and Regulatory Affairs. 8.Perform internal audits and support external audits (FDA, ISO, etc.) 9.To follow the cGMP Rules and regulation. Working knowledge of regulatory standards. 10.Responsible for preparation, review and approval of DQ, IQ, OQ and PQ documents for new equipment or existing equipment. Show more Show less