Senior Manager, Manufacturing Injectables

Job Description

Description: The role involves ensuring CGMP compliance and supervising overall production activities of manufacturing area of multiple assigned manufacturing lines. Additionally, the position requires reviewing and maintaining online documents. Essential Functions: Responsible for preparation, review, revision, control, and implementation of standard operating procedures . Responsible for preparation & review of the master documents of production . Responsible for preparation and review of Protocols and reports based on the requirements. Responsible for Document management like BMRs, BPRs, Master SOPs etc.. Responsible for the handling of Change Control, Deviations, CAPA, Investigation etc.. Responsible for line clearance activity before commencing the operations like manufacturing, filling, capping & packing operations . To generate general purchase indent for departmental general items. Responsible for preparation of production planning on monthly and daily as per the requirement and availability of materials. Responsible to prepare daily production report as per the production achieved. Responsible to ensure that all equipment’s and lines are in validated and calibrated status. Responsible to follow cGMP, GDP, and discipline in the department and to ensure that all employees follow the same. Ensure the compliance & discipline . Responsible to makeshift schedule . Responsible to check that all the records and logbooks related to manufacturing, filling and sterilization of equipment’s Additional Responsibilities: Responsible to give training to all the subordinates, technicians, and operators of the department. Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance. Responsible to attend the training as per training schedule and to ensure training as per TNI. Education: Bachelors Degree (BA/BS) B. Pharm - Required Master Degree (MS/MA) M. Pharm - Preferred Master Degree (MS/MA) M. Sc. - Preferred Experience: 12 years or more in 12 - 16 Yrs Skills: Specialized Knowledge: Licenses: