Vaccine Inspector

2 weeks ago

Sydney, New South Wales, Australia Pivotal Personnel Pty Ltd Full time
Mon to Fri 2:30pm to 10:30pm

  • Location: Banks meadow
  • Ongoing casual role


Our client is seeking operators responsible for filling of vaccines and sterile injectables in order to meet the Master Production Schedule.


_Responsibility:
_

  • Keep aseptic gowning qualifications current at all times
  • In the filling rooms, assemble pre sterilised filling machine components (where required) in aseptic manner to get the filling machine ready for filling operation.
  • Operate filling machines and other equipment to aseptically fill vaccine / sterile injectables containers maintaining high GMP standards.
  • Carry out environmental (viable + non viable) monitoring in filling and changing rooms and transfer all samples to QC laboratory.
  • Set up and participate in pressure testing filling lines
  • Carry out personal environmental monitoring required for each entry and/or exit out of clean rooms and transfer all samples to QC laboratory.
  • Prepare all filling equipment and materials for commencement of fill (including weight checks, calibration of machinery, particle counters)
  • Communicate with blending and line operators as and when required to commence filling, reporting any issues faced in filling rooms.
  • Disinfect and clean filling & change rooms as per company procedures maintaining strict GMP standards at all times
  • Prepare filling rooms for fumigation
  • Conduct line checks
  • Provide product samples to QC for testing
  • Check for rejects
  • Report any issues observed in real time to the supervisor
  • Carryout steps as per written procedure to transfer vaccine filling container and stoppers to bottle storage are from warehouse.
  • Wash and prepare filling equipment (Where Required) ready for autoclaving.
- maintain work area and equipment in accordance with GMP and GHP.

  • Ensure the product bin status labels and product details are correct all time.
  • Set and operate non viable particle counter for Grade A zone in filling room in coordination with operator.
  • Set and operate leak testing equipment and record all results on batch records. inform area supervisor immediately if any leaking container seen.
  • Check all codes and lot numbers match the issue records.
  • Ensure completion of logs and batch records in real time after completion of each step following GMP principle.
  • Working in other production area as and when required by production schedule (Pharmaceutical production, Media preparation and packing).

_As Person:
_

  • Minimum 1 years experience in production of sterile products.
  • Hands on aseptic technique/ practices.
  • Current knowledge on clean room gowning.
  • Previous experience working in confined space.
If you are ready for the next challenge and if the above sounds like you then hit the "Äpply" button

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