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
Qualifications
Qualification: M.Pharm./ B.Pharm./ M.Sc.
Exp.: 3-7 years
Candidate shall have experience in the Manufacturing of Injectable Products