Production Associate
3 weeks ago
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
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.
- 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 assembling 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.
Be part of building the bridge between life changing therapies and patients.
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