Production Operations Specialist
22 hours ago
As a key member of our PCI Pharma Services team, you will be responsible for ensuring the efficient labelling and packaging of pharmaceutical products.
Our team is dedicated to delivering high-quality products to our clients, and we are seeking a skilled Production Associate to join our ranks.
Main Responsibilities:
- Conduct labelling and packaging activities as scheduled by the Production Lead.
- Complete batch records concurrently with labelling and packaging activities and ensure all steps are completed.
- Undertake facility cleans and day-to-day equipment calibrations as required by the batch records and company SOPs.
- Remove production waste and rubbish after production is completed and prepare for line clearance.
- Perform line clearance sign-off as requested.
- Participate in procedural updates and provide input for process designs.
- Assist in the maintenance of the cGMP facility license and participate in facility audits.
Requirements:
- Ensure the required Batch Record has been approved and QA issued prior to use.
- Verify the picked released stock and equipment for labelling of clinical supplies and packaging.
- Assemble kits of finished products in accordance with the Batch Records.
- Take samples in accordance with the batch record instructions.
- Review production batch records and ensure completion and signature prior to Production Senior Associate review.
- Report deviations to the Production Senior Associate or Production Lead.
- Clean equipment in accordance with SOPs.
About Us:
PCI Pharma Services is a global contract development and manufacturing organization (CDMO) that enables the biopharmaceutical industry to improve lives through the delivery of life-changing therapies. We are committed to delivering high-quality products and exceptional service to our clients.
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