Senior Executive- Filling Inj Manufacturing

15 hours ago

Ahmedabad City Gujarat India Amneal Full time ₹ 12,00,000 - ₹ 24,00,000 per year
Description
  •  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

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