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Production Associate

2 months ago

Moorabbin, Australia PCI Pharma Services Full time
Production Associate Role

At PCI Pharma Services, we are committed to delivering life-changing therapies to patients around the world. As a Production Associate, you will play a critical role in our global network, working closely with our teams to pioneer and shape the future of our company.

Key Responsibilities
  • Primary responsibility for labelling and packaging activities in the production facility, as scheduled by the Production Lead.
  • Responsible for completing batch records concurrent with labelling and packaging activities and ensuring all steps are completed.
  • Undertake facility cleans and day-to-day equipment calibrations as required by the batch records and company SOPs, and record these activities using the applicable document.
  • Responsible for removal of any production waste/rubbish once production is completed and for preparing for line clearance.
  • May be requested to perform line clearance sign off.
  • Provided with practical training and involved in procedural updates and process designs.
  • Assist in the maintenance of the cGMP facility license and may be required to assist in facility audits.
  • Ensure the required Batch Record has been approved and QA issued prior to use.
  • Ensure the required packaging room is ready for use and that appropriate Room logs and registers are completed.
  • Follow the company gowning and hygiene requirements.
  • Verify the picked released stock and equipment for labelling of clinical supplies and packaging, and assemble kits of finished products in accordance with the Batch Records.
  • Ensure that samples are taken in accordance with the batch record instructions.
  • Review production batch records and ensure that these are completed and signed prior to Production Senior Associate review.
  • Ensure that all deviations are reported to the Production Senior Associate or Production Lead.
  • Clean equipment in accordance with SOPs.
  • Review labels and randomization lists against label approval forms and master randomization lists prior to commencing batch manufacture.
  • Prepare, review, and maintain SOPs relevant to the Production facility.
  • Assist other departments as required.

We are committed to building a better tomorrow, and we invite you to join us on this journey.