Shipping Validation - Biopharmaceutical
Do you have experience of cold-chain, shipping validation within a GMP environment? If so, I have the role for you!
Global Biotech company currently undergoing a large investment project to increase manufacturing to meet the rise in global demand to treat rare genetic diseases.
The role will focus on the review and appraisal of existing shipping configurations, authoring and executing shipping validation protocols and authoring the subsequent reports.
Duties will involve: To co-ordinate and execute Global Shipping validation activities for Temperature Controlled shipments via air, road and short sea
• Shipping validation documentation – drafting, reviewing and approving documentation.
• Passive shipper qualification for the Shipping and Distribution of temperature-controlled products
• Shipping lane assessment and qualification for the introduction of new lanes and products
• Review of current shipping systems
• Introduce new shipping system for frozen material via international airfreight
• Responsible for the core aspects of Shipping Validation SOP's, specifications and validation plans
• Actively contribute to project teams.
• Commissioning, qualification and validation experience in vaccine or sterile product manufacturing would be an advantage (min 3 – 5 years)
• Thermal mapping experience using a thermal mapping system such as Kaye or Expert Val
• Experience in GMP/ IMB/FDA environment advantageous.
• Strong technical writing and communication skills
• Shipping / Logistics & Validation
If this role is of interest to you, apply now for immediate consideration.
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