Supply Chain Analyst – Packaging and Labelling
- East Hertfordshire, England (GBR)
- £150 - £180 Per Day
- 12 Months
- Start date: ASAP
- Ref: GSK0JP00102598
- packaging
- labelling
- supply chain
- gmp
- pharmaceutical
- clinical studies
- quality assurance
- operations
- compliance
- cmos
Supply Chain Analyst – Packaging and Labelling
Ware
12 Months
£180p/d PAYE Max
At GSK, Clinical Supply Chain organisation within MDS is responsible for the timely provision of packed clinical supplies from internal operations in support of clinical studies across all the GSK R&D pipeline (phases 1-4). External Packaging Operations, is responsible for managing the technical content and delivery of these activities from Third Party Contractors (TPCs). The team members role in External Packaging Operations is to:
• Provide project management of the technical content of work packages associated with allocated projects, in liaison with supply chain contacts in CSC (Clinical Interface), R&D Procurement, External Quality Assurance (EQA) and external TPC contacts.
• Input technical expertise and TPC oversight at all stages of the work packages
Work package scope: primary and secondary packaging, labelling and distribution activities, and associated supporting activities
Project Delivery:
• Manage work packages requirements to secure delivery to agreed timelines for allocated projects.
• Provide technical input in scoping requirements for externalisation; liaise with internal stakeholders to assess timelines and resources required.
• Define technical requirements within technical documentation; facilitate materials delivery to TPCs; review and approve TPC batch documents and/or label texts; technical review of completed batch documentation.
• Liaise with TPCs to agree technical requirements, monitor progress and resolve issues; seek advice from other team members/line manager/EQA; feedback on progress to CSC (Clinical Interface) contacts.
• Use planning tools to keep progress on track; keep the team informed of project progress through regular project tracking meetings; liaise with business partner lines to manage/adjust timelines and priorities; escalate issues and concerns as they arise.
Quality:
• Ensure all activities are delivered compliant to defined processes and GMP; concerns / risks are identified.
• Ensure appropriate and complete records arising through operational activities are maintained at GSK and TPCs in compliance with GMP and that meet data integrity standards.
• Maintain quantitative and performance metrics for projects managed.
• Support quality or safety investigations and internal or external agency audits, as required.
General:
• Engage and assess supplier technical proposals against project requirements and make sourcing recommendations in alignment with procurement.
• Maintain an awareness of internal PLD operational processes (Zebulon, NC & Harlow, UK), initiatives and planned changes through contact with key partners GSK teams and stakeholders.
• Maintain good industry knowledge of PLD working practices / ways of working and awareness of key CMO capabilities.
• Represent the team and GSK in supplier BRMs (Business Review Meetings) and initiatives at supplier/CMO sites as required.
• Track and monitor External Packaging Operations and TPC performance to ensure operational commitments meet agreed timelines and quality KPIs.
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
• 3+ years experience working in an R&D GMP environment
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
• Experience working in an operational PLD role within Clinical Trial Supplies.
• Knowledge of Clinical Trial Supply CMOs and their capabilities
• Knowledge of the pharmaceutical and clinical development processes and their relationship to the clinical supplies delivery processes; aware of clinical supply GMP requirements and standards.
• Lean Sigma training / experience
• Project Management training / experience
• Experience demonstrating organizational and planning skills coupled with strong written and oral communication skills
• Demonstrated capability to work with aggressive and changing timelines and with limited information and without defined absolutes.
• Knowledge of the technical challenges with regards to investigational product packaging and labelling.
• Demonstrated experience working in a third party management / oversight role.
