Key Responsibilities: • Responsible for document management like BMR’s, BPR’s, master SOP’s etc. • Responsible for preparation & review of the master documents of production. • Responsible to ensure UAF working in area. • Responsible for the handling of change control, deviations, investigation & CAPA, etc • 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 HOD’s instruction and guidance. • Responsible for line clearance activity before commencing the operations. • Responsible to check that all the records and logbooks related to aseptic manufacturing, vial filling and vial sealing machine. • Responsible for preparation, review, revision, control and implementation of standard operating procedures of sterile manufacturing department. • Responsible to ensure cleaning and sanitization of General, Controlled & Aseptic area. • Inform immediately to department functional head for any observation/disturbance with respect to documents and machines found in area. • Responsible for monitoring all the activities related to General, Control & Aseptic area. • Responsible to ensure qualification and calibration status of equipment and instruments to avoid due/overdue. • Responsible to ensure scheduled activity of respective area/equipment/instruments. • Responsible to attend training as per schedule and to ensure training and work as per TNI. • Follow the cGMP, Good Document Practice and discipline in the Company Premises. Skills: • Filling, stoppering and sealing | Expert • Equipment Operation & Cleaning (CIP/SIP) | Proficient • Dispensing | Proficient • Sterilization through Autoclave | Proficient • Mixing | Proficient • Decartoning | Expert • Washing | Proficient • Terminal Sterilization | Proficient • Good Manufacturing Practice (GMP) | Proficient • Batch Documentation and Record Review | Proficient • Cleaning & Line Clearance | Beginner • People Management & Team Leadership | Beginner Qualification: M.Pharm./ B.Pharm./ M.Sc. Exp.: 3-7 years Candidate shall have experience in the Manufacturing of Injectable Products