A rare opportunity to join the Clinical Trial Supply department of a major global Pharmaceutical company. Do you have experience in CTS Packaging, combined with excellent communication and project management skills? Whether you have worked within a Pharma company, Clinical Supply service company or other 3rd party Packaging company, this could be an excellent way to progress your career. Based on site in Sandwich, Kent, this is a newly created Packaging Project Co-ordinator position on an initial 12-month contract (with strong chance of extension on a rolling basis), paying the equivalent of up to £35,000 salary depending on experience.
As part of the Clinical Supply Packaging (CSP) team, you will be a central point of contact for stakeholders across and outside the business, including Supply Chain, Project Coordinators at contract packaging organisations, Global CSP colleagues, Quality, Global Analytics, Distribution & Inventory Management and Planning teams.
Using your Project Co-ordination / Project Management skills to the full, you will work with these different groups to ensure that CSP activities are performed accordingly to agreed timelines and to the required packaging specifications. Your duties will include:
- Review and interpret the clinical protocol to develop practical and efficient packaging designs for Clinical Supplies. Generate and approve Clinical Packaging Requests and Clinical Label Requests.
- Ensure the Packaging Diagram contains sufficient detail regarding the packaging to be completed.
- Assess packaging requirements and procure specific materials to meet study needs, approve tooling and card designs.
- Using modules within the Current Approved Inventory Management system, design kit structures, model protocols, design labels, monitor and track the approval of country panels and generate packaging requests to enable the fulfilment of packaging operations, such that packaged materials can be shipped or transferred for distribution to clinical sites or depot holding areas.
- Facilitate the use of Clinical Supply Distribution System for importing packaged inventory for distribution purposes.
- Update scheduling tools with the progress of work and immediately raise issues if escalation is required
- Work with Inventory Management, Quality Assurance and Global Analytics to co-ordinate and drive the progress of the packaging operation to ensure timelines are met.
- Manage multiple projects working with colleague Packaging Coordinators and master planner to resolve external packaging operation schedule conflicts and issues.
- Utilise cost estimating tools for external operations to provide quotations for budgetary purposes; compare quotations received from vendors to the cost estimating tool and raise any significant discrepancies to line management.
- Co-ordinate the fulfilment of stability packaging requests.
- Approve quotes for contract packaging and/or labelling
- Communicate the study packaging and/or labelling requirements to 3rd party contract packaging/labelling organizations.
- Generate/prepare study documentation and where appropriate, carry out a final review of packaging documentation before submission to QA.
- Analyse and manage internal/vendor deviations in partnership with Quality Assurance
- Utilize Project Management skills to plan, schedule and assess risks to complete the job.
- Review internal/contractor packaging and labelling documents making recommendations where appropriate to ensure compliance with Clinical Supply Packaging procedures, study requirements and Good Manufacturing Practice.
- Develop strong relationships with global contract packaging organisations.
- Coordinate multiple packaging and labelling operations at various global contract packaging organizations.
- Generate purchase orders, ensure timely approval for vendor. Track project costs, receipt order and insure payment gets to the vendor by follow up with accounts payable when needed.
- Perform oversight visits to contract organisations to ensure contractor compliance with Global outsourcing procedures.
- Support internal GMP audits/self inspections.
The successful candidate will ideally have a scientific degree (though this is not essential), combined with experience within a Clinical Supply Chain setting. You will need to have some packaging experience and an understanding of CTS packaging requirements, including associated packaging technology and its application within a GMP and / or GCP environment. You do not need to be an expert in packaging materials / packaging technology but it will be a strong advantage if you do. First and foremost, we are looking for someone with excellent Project Management skills and the ability to communicate well with internal teams and 3rd party clinical supply businesses.
This is a 12-month contract position, in Sandwich (Kent), paying up to £35,000 salary depending on experience. Full details will be provided on application.