Global Production Specialist
1 week ago
Life changing therapies. Global impact.
We are PCI Pharma Services.
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 Pharma Services.
Key Responsibilities:
- Production Associates have primary responsibility for the day to day labelling and packaging activities in the production facility as scheduled by the Production Lead.
- Production Associates will be responsible for completing batch records concurrent with labelling and packaging activities and ensuring all steps are completed.
- Production Associates will 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.
- Production Associates are responsible for removal of any production waste/rubbish once production is completed and for preparing for line clearance.
- Production Associates may be requested to perform line clearance sign off.
- Production Associates will be provided with practical training and will be involved in procedural updates and provide input for process designs.
- Production Associates also assist in the maintenance of the cGMP facility license and may be required to assist in facility audits.
- 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.
- 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.
Be part of building the bridge between life changing therapies and patients.
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