Manager, Manufacturing Injectables

As a candidate, you will be responsible for the following tasks: - Updating on self-hygiene. - Preparing, reviewing, revising, controlling, and implementing standard operating procedures of the sterile manufacturing department. - Preparing and reviewing Protocols and reports based on the requirements. - Managing Document management like BMRs, BPRs, Master SOPs etc. - Handling Change Control, Deviations, CAPA, Investigation, etc. - Generating general purchase indent for departmental general items. - Preparing production planning on a monthly and daily basis as per the requirement and availability of materials. - Creating daily production reports based on the production achieved. - Ensuring that all equipment and lines are in a validated and calibrated status. - Following cGMP, GDP, and discipline in the department, and ensuring all employees comply with the same. - Providing training to all subordinates, technicians, and operators of the department. - Performing activities beyond the defined job responsibilities as per the requirement of HOD, following HOD's instructions and guidance. - Attending training as per the training schedule and ensuring training as per TNI. - Preparing and reviewing all-master documents of production. - Ensuring cleaning, sanitization, and operation of machines as per Standard Operating Procedures. - Controlling aseptic area operations like sterilization, manufacturing, washing & dehydrogenation, filling and sealing, etc. - Conducting line clearance activity before commencing operations like manufacturing, filling & sealing. Skills required for this role include: - Compliance with Good Manufacturing Practices (GMP) and regulatory standards (USFDA, MHRA, WHO, etc.). - Completion of Batch Packing Records (BPRs), logbooks, and deviation reports. - Maintaining traceability and strictly following SOPs.,