Vaccine Inspector

2 weeks ago

Sydney, 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 auto-claving.
- 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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