QMS Lead

To lead and manage overall manufacturing QMS activities with the support of a team • Responsible for preparation, review, revision, control and implementation of standard operating procedures of sterile manufacturing department & warehouse department. • Responsible for preparation & review of the master documents of sterile manufacturing department and warehouse department for Parenteral facility -I, II & III. • Responsible for preparation and review of Protocols and reports based on the requirements. • Responsible for Document management like BMR’s, BPR’s, Master SOP’s etc. • Responsible for the handling (Preparation/Initiation/Execution and Approval) of Change Control, Deviations, CAPA, Investigation, QRM, Protocol, Purchase specification etc. for sterile manufacturing department & warehouse department. • Responsible for the Review and Approval of CFT’s Change Control, Deviations, Investigation, QRM, Protocol, other documents etc. • Responsible to follow cGMP, GDP and discipline in the department and to ensure that all employees follow the same. • Responsible to give training to all the subordinates, technicians and operators of the department. 10 • Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance. • Responsible to attend the training as per training schedule and to ensure training as per TNI.