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Job ID :
64718BR
Location :
Australia - Brisbane
:
Job Description
  • At least 4-5 years experience in USP including cell culture, single-use bioreactor (WAVE and SUB), single-use clarification, use of MFCS and cell banking in compliance with the relevant production protocols in a clean room environment under cGMP conditions.
  • Experienced in troubleshooting of fed-batch, perfusion and clarification processes as well as equipment troubleshooting.
  • Organised individual who is able to perform planning and scheduling as well as organising production suite, supplies, equipment and logbooks.
  • Support and implementation of new procedures and/or equipment in the OPS department
  • Review, revise and author manufacturing batch records, logbooks and material reconciliation.
  • As the SME of USP unit operation and equipment, training co-workers that are unfamiliar with certain unit operation or handling of specific equipment, including approval of on-the-job trainings.
  • Proposes and implements Corrective and Preventive Actions and support the on-time closure Deviation Reports and Change Controls
  • Being the lead investigator for Minor and Major Deviation Reports.
  • Pro-active in implementation of lean (OE) initiatives and continuous improvements under minimal direction.
  • Adhere to Patheon cGMP Quality Management System and the Patheon EH&S requirements.


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