GxP Technician

Responsible for the management of product safety, legality and quality as per relevant

Quality Management System procedures.

• Participate in training provided by clients and keep training up to date and in compliance with client Individual Training Plans on client platforms where applicable.
• Ensure all documentation generated by McArdle Skeath relating to the storage of the material adheres to ALCOA Principles (Accurate, Legible, Contemporaneous, Original, and Attributable).
• Maintain adherence to Good Distribution Practices & McArdle Skeath and the client (where applicable) SOPs.
• Perform inbound and outbound external visual inspection of the client materials’ outer packaging for damages, tampering and signs of contamination as per client procedures.
• Sign/date/time of receipt and mark unchecked delivery documents on arrival of goods from client vendors.
• Ensure all relevant documentation (e.g. CoA) received from the supplier is electronically sent to the client in a timely manner where applicable.
• Ensure Temp tales are stopped and downloaded onto ColdStream and are physically returned to the client where applicable.
• Receipt into client WMS (where applicable), generate, and apply labels as per client procedures.
• Download inventory report to excel and send to the client as required.
• Review client WMS daily for material movement requests (e.g. Stock Transfer Orders, movement of material in QI status etc.) to and from the client.
• Ensure all inventory is put away in a timely manner upon the receipt of the correct paperwork into the MSK facility.
• Ensure that client products are only stored in the correct locations and proper segregation, storage and quarantine/special areas are identified and controlled.
• Ensure all client inventory which is damaged is appropriately labeled and stored in the quarantine area and segregated from other stock.
• Create picking and pack lists from the client WMS where applicable.
• Assemble orders on client pallets or pallet boxes and shrink wrap as needed.

Skills Required

• Ability to rigorously adhere to procedures and processes.
• System experience – SAP and/or Index
• Excellent attention to detail
• Ability to work within GxP regulatory frameworks and client specific processes.
• Excellent English verbal and written communication skills.
• Willingness to learn
• Enjoy working as part of a team
• Experience using the Microsoft Suite of programs and excellent computer skills
• A 3rd level qualification would be a distinct advantage.

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