Start date: asap

Contract duration: 12-month contract

Location: Ware – 2 days per week on site

PAYE rate: £157.67 per day

Job Purpose:

• Effectively execute pre-production activities to enable on-time job handover within Global Packaging Operations.

• Timely progression and approval of clinical site temperature excursions to ensure continuity of clinical supplies.

• Providing support to the Global Packaging Operations and Clinical Interface teams within the Clinical Supply Chain function

• Seek and support process improvement opportunities.

• Veeva activities to supported study leads/studies

• Participate in management monitoring activities for Pre-Production Management

• Support aligned Supply Chain Planners & Study Chain Study Leads as required

Key Responsibilities:

• On-time execution of pre-production tasks (such as PMD Manufacturing Request (MRs) approval) in order to maintain the supply of clinical trial material

• Right first-time documentation completion

• Management of temperature excursions for local depots, in-transit excursions from local depots, and clinical site excursions

• Veeva activities to support study leads/studies for maintaining integrity of clinical trial information.

• Quality – Management monitoring audits

• Approval of GMP MRs in local inventory management system (PMD) for both internal and external packaging activities.

• Management of inventory: movement of stock around the network as required ensuring the right stock is in the right place at the right time, timely destruction of expired materials

• Maintenance of demand plans within local MRP system (Supply Management Tool) in conjunction with the Supply Chain Study Lead / Planner within Clinical Interface

• Management of temperature excursions at clinical sites, ensuring all relevant documentation is retained in the appropriate archiving / trial master file system.

• Understand processes across the supply chain in order to ensure timely and accurate delivery of both information and documentation to the next node in the supply chain

• Ownership of the post-packaging assessment and release for new and additional countries participating in clinical studies

Requirements:

University degree or equivalent experience, plus demonstrated computer skills in Microsoft office suite of products.

• Capable of accurately reviewing, editing and approving documentation for completeness, with attention to detail.

• Demonstrates an understanding of clinical packaging and manufacturing terminology.

• Possesses working knowledge of Good Manufacturing Practices (GMPs).

• Able to manage own time and workload priorities, self-motivated.