Job Description

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