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

BE-Instrumentation would be Preferred. Candidate having 15-20 years of experience. Key Responsibility Areas 1.Ensure that the written standard operating procedure, preapproved instruction and all related documents used to maintenance of equipments are used to produce products as per planning, are current and complete wrt good manufacturing practices; factual reporting of the maintenance metrics to the senior management. 2.Prepares planning and implementation of preventive and shutdown maintenance, electrical and mechanical utilities to ensure minimum breakdown and equipment reliability. 3.Ensure the facility, equipment and personnel practices used for the maintenance process is complaint to the good manufacturing practices and manual and regulatory requirements 4.Ensure that all maintenance deviation are reported & evaluated and that critical deviations are investigated and the conclusions are recorded and timely escalated to the senior management 5.Ensure that personnel performing work affecting conformity to product requirements are competent on the basis of appropriate education, training, skills and experience and are kept motivated and engaged. 6.Evaluating proposed changes in, process or equipment; and ensure that new and, when appropriate, modified facilities and equipment are qualified and propose saving techniques for cost and energy 7.Responsible for conducting Risk Assessments in order to identify areas and actions that could pose a threat to the effective implementation of manufacturing process and timely completion of the identified action items. 8.Perform the task assigned by the supervisor or management for any other job roles and responsibilities as per business needs. Show more Show less