Qualified Person

University of Oxford - Nuffield Depart of Medicine (NDM)

Nuffield Depart of Medicine (NDM), Clinical Biomanufacturing Facility, Churchill Drive, Headington. Oxford

We are seeking an experienced scientist to undertake Qualified Person (QP) responsibilities as defined in the Code of Practice for Qualified Persons of the IoB, the RPS or RSC as appropriate.

You will be responsible for certifying Investigative Medicinal Products (IMP) for use, ensuring compliance of operations with regulatory requirements and QP declaration for imported products, including auditing of third party manufacturing facilities. You will assist the Senior QP with the portfolio of QP activities whilst legally remaining solely responsible for your QP activities.

As a Qualified Person you must have relevant experience and meet the eligibility requirements to be able to be named on sterile MIA (IMP). You will possess a science degree or PhD (or be near completion) in the biological sciences. You must have a flexible attitude, and be prepared to occasionally travel overseas and undertake in depth pharmaceutical audits. Excellent interpersonal skills with an ability to work with and advise senior members of academic staff are essential. You must be able to work independently, under pressure without compromising on deliverables, have solid organisation and planning skills plus an attention to detail.

Experience of manufacturing vaccines/advanced therapy medicinal products (ATMPs)/adjuvants to meet the GMP requirements is essential. Knowledge of medical devices, quantitative purification using chromatography or density gradient ultracentrifugation, along with experience of hosting regulatory inspections and importing clinical trial material manufactured out with the EU, would be desirable.

You will also be required to upload a CV and supporting statement which explains how you meet the selection criteria for the post.

The post is available as a fixed-term contract for 2 years in the first instance.

For general enquiries please email: gary.strickland@ndm.ox.ac.uk

Only applications received before 12.00 noon on 11 November 2016 will be considered.


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South East England