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Clinical Supplies Project Coordinator

4 months ago

Wirral, United Kingdom Ark Talent Group Full time

Title: Clinical Supplies Project Coordinator (Packaging & Labelling)

Length: 12 months

Location: Wirral

Our client is looking for a Clinical Supplies Project Coordinator to support delivery of clinical supplies through management of projects.

Key responsibilities will include:

- Liaise with responsible Drug Supply Manager on aspects of clinical supplies packaging and labelling design and study requirements
- Ensures production schedules meet agreed upon on-time delivery date of finished supplies
- Responsible for coordinating availability of all deliverables (e.g. drug product and components, randomization file and label text)
- Generates, reviews and approves internal and external packaging and labeling production orders in accordance with the clinical trial design and product specifications
- Responsible for the creation and/or release of Bill of Materials and process orders in SAP for assigned projects
- Executes all required SAP transactions such as goods receipt and goods consumption
- Converts planned orders (print and production) into process orders completing all required user fields and adding long text as required
- Compiles supporting documentation and delivers a body of evidence (batch records) that supports the release of finished supplies for clinical use
- Manages external manufacturing transactions in SAP and sample execution
- Reviews and approves vendor generated production orders and other related documents (i.e. change orders)
- Executes applicable change controls and deviations in a quality management system
- Authors new and/or reviews existing procedural documents

**Requirements**:

- Will be able to demonstrate the ability to plan, manage and execute multiple projects and deliver to critical timelines
- Will have strong project management skills
- Will have good decision making and organisation skills
- Will be able to demonstrate the ability to effectively communicate ideas and influence others to achieve results
- Will have knowledge of and the ability to understand and implement regulatory and cGMP principles
- Will have knowledge of ERP/MRP systems and supply chain principles
- Will be educated to a BSc or equivalent in pharmacy, engineering, life sciences or a related discipline
- Will have worked within the pharmaceutical industry

**Job Types**: Full-time, Temporary contract, Freelance
Contract length: 12 months

**Salary**: £20.00-£24.00 per hour

**Benefits**:

- Work from home

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Wirral: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's (preferred)

**Experience**:

- project management: 1 year (preferred)
- ERP/MRP: 1 year (preferred)
- cGMP: 1 year (preferred)
- Regulatory: 1 year (preferred)
- clinical: 1 year (preferred)
- pharmaceutical industry: 1 year (preferred)

Work Location: In person

Reference ID: CL