Radiopharmacy Project Lead
LabLogic Systems
Sheffield
Full-time
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This role is a full time, office\-based position. However, the role involves frequent travel to our customer sites both in the UK and internationally.
As a Project Lead, you will oversee projects for our market leading nuclear medicine LIMS (Laboratory Information Management System), PETra and SPECTra. The ideal candidate will have a background in PET/SPECT production and be familiar with regulatory compliance.
This is a customer facing role with a high level of interaction to advise on numerous technical aspects with respect to implementation, processes and applications.
Responsibilities
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- Take ownership of project delivery, including scope, timelines, and risks, while coordinating cross\-functional teams and acting as the primary customer contact.
- Own and lead the end\-to\-end validation lifecycle including Validation Planning, IQ, OQ, and support of PQ activities.
- Develop, review, and maintain validation documentation.
- Act as Subject Matter Expert (SME) for PETra and SPECTra, providing configuration expertise, best practice guidance, and support for pre\-sales activities and solution design.
- Liaise with application developers to drive product improvements and ensure alignment between customer needs and product capability.
- Provide SME support for customer audits and inspections.
- Deliver training, prepare materials and provide ongoing coaching to new customers as part of a newly installed system.
- Support User Acceptance Testing, post\-install validation, including helpdesk support where requested.
- As SME, test and approve updated applications during the release process, taking ownership of customer upgrades, including on\-site software testing where required.
- Support sales team in:
+ Bid process, tender document review.
+ SME support for specific technical questions.
+ Attend commercial conferences and user group meetings.
- Presentation requirements for group/users as directed.
- Company SME for guide, advise and update colleagues on best processes and practices within Nuclear Medicine.
Requirements
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Essential
- In\-depth knowledge of radiopharmaceutical production processes.
- Understanding of GMP and regulatory environments (GAMP 5, Annex 11, 21 CFR Part 11 knowledge).
- Ability to work with end users on\-site to ensure successful deployments, training and ultimately customer satisfaction.
- Ability to work with the internal development and QA teams to help drive future developments.
- Ability to enhance and maintain training materials.
- Experience delivering basic and/or advanced training.
- Ability to understand and work with IT teams at customer facilities.
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