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Job Opportunities at IMP 

Job advert: Qualified Person (clinical trials)

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Full time position, part time considered for the right candidate.

Annual renumeration £55k to £80k depending on experience. 

Ideally suited to a dynamic Qualified Person who wants to move their career forward with the opportunity to move into a director role and work with an international team specialising in investigational medicinal products.  The position will require support for ongoing and new projects throughout the UK, EU and worldwide. 

The role will involve being responsible for the control and oversight of the Quality Management System working within an experienced and efficient team.  Training will be provided with the opportunity to develop skills and knowledge within the UK and international businesses. 

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Routine requirements of the role include:

  • Qualified Person batch review and certification of investigational medicinal products

  • Issuing and reviewing approved documents to support day to day operations

  • Communication with Operations staff and other QPs regarding quality matters

  • Communication with clients and IMP staff regarding project quality matters

  • Problem solving to assist team members in identifying and eliminating problems

  • Supporting site Quality Assurance staff when hosting audits and visits

  • Review of reports and quality documents

  • Remain abreast of current and upcoming legal requirements as part of continuous professional development

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Working in a fast-paced environment with experienced and knowledgeable pharmaceutical professionals to ensure:

  • Timely decisions are made for batch certification for UK clinical trials including GB QP Oversight and supporting international releases of clinical trial products. 

  • Contribution to the daily delivery of risk analysis, change control, deviations, CAPA, complaints, training, internal audits, product quality review and management review, document oversight, quality agreements to a consistently high standard.

  • Contribution to the monthly / quarterly Quality Management meetings and input into management requirements for the Quality cost centre of the business. 

  • Audit of pharmaceutical facilities throughout the UK, EU and worldwide to support ongoing and new projects. Audits may cover API manufacture, finished product manufacture and primary packaging, testing facilities including microbiology.  

  • Implementation of new and upcoming legal requirements and good practices throughout the business. 

  • Batch certification and release of medicinal products (sterile and non-sterile) for clinical trials – note: Steriles experience is ideal but not essential

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Review and approval of batch documentation, quality assessment of products intended for clinical trials.

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Qualification requirements:  eligible to act as a QP for IMPs, ideally with a broad range of experience covering multiple dosage forms.

                              Closing date:  Friday 14th February

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