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Production Specialist

1 month ago

Moorabbin, Australia PCI Pharma Services Full time
Job Summary

We are seeking a Production Specialist to join our team at PCI Pharma Services.

About PCI Pharma Services

PCI Pharma Services is a global leader in contract manufacturing, packaging and clinical trial services for the biopharmaceutical industry. Our mission is to bridge the gap between life-changing therapies and patients.

Responsibilities
  • The Production Specialist will be responsible for day-to-day labelling and packaging activities in the production facility as scheduled by the Production Lead.
  • Completing batch records concurrent with labelling and packaging activities and ensuring all steps are completed.
  • Undertaking 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 (e.g. within batch records or using the applicable Forms or Registers).
  • Removal of any production waste/rubbish once production is completed and preparing for line clearance. The Production Specialist may be requested to perform line clearance sign off.
  • Provided with practical training and involved in procedural updates and providing input for process designs.
  • Assist in the maintenance of the cGMP facility license and may be required to assist in facility audits (e.g. PCI internal audits and audits conducted by Clients/Sponsors and Regulatory Authorities).
  • Ensuring the required Batch Record has been approved and QA issued prior to use.
  • Ensuring the required packaging room is ready for use and that appropriate Room logs and registers are completed.
  • Follow the company gowning and hygiene requirements.
  • Verifying the picked released stock and equipment for labelling of clinical supplies and packaging, and assembling kits of finished products in accordance with the Batch Records.
  • Ensuring that samples are taken in accordance with the batch record instructions (e.g. retention samples).
  • Reviewing production batch records and ensuring that these are completed and signed prior to Production Senior Associate review.
  • Ensuring that all deviations are reported to the Production Senior Associate or Production Lead.
  • Cleaning of equipment in accordance with SOPs.
  • Reviewing labels and randomization lists against label approval forms and master randomization lists prior to commencing batch manufacture.
  • Preparing, reviewing and maintaining SOPs relevant to the Production facility.
  • Assisting other departments as required.
About the Role

This is an excellent opportunity to join a dynamic team and contribute to the success of PCI Pharma Services. The ideal candidate will have a strong understanding of production processes and a keen eye for detail.

Requirements
  • A minimum of [insert salary] per annum based on experience.
What We Offer

We offer a competitive salary and benefits package, including health insurance, retirement savings plan, and paid time off. Additionally, we provide ongoing training and development opportunities to help you grow your career.