job details for:
Clinical Research - Qualified Person Jobs (QP) - Europe (Belgium, Brussels)

Clinical Research - Qualified Person Jobs (QP) - Europe (Belgium, Brussels) (Job Ref: WR/JOBS/26401-12886)

Job Description :

Flame Pharma - Clinical Research - Qualified Person Job (QP) - Europe (Belgium, Brussels)

Europe, Belgium, Brussels:  Excellent Package

With a great reputation for constantly delivering high performance clinical development, our client is considered to be one of the very best contract research organisations throughout the world.  With extensive European expansion, we are recruiting a Qualified Person (QP) to provide QP release services for Investigational Medicinal Products imported from outside the EU.  This exceptional opportunity will be reporting to the Director, consulting for Europe.

The Role

The Qualified Person will set up and review Quality Assurance Technical Agreements with the Trial Sponsor and carry out audits of GMP facilities involved in the manufacturing of medicinal products used in the clinical study.  They will communicate internally with Project Management, Clinical Supply, Clinical functions as well as with the Trial Sponsor externally.  The QP will set up and maintain Product Specification Files (PSF) for the medicinal products to be released for a clinical study plus check required GMP & Quality Control documentation in conformity with EU GMP and PSF/IMPD/Import and Export Authorisations/Competent Authorities & Ethics Committees approvals.  The successful QP will release medicinal products to be used in a clinical study, maintain a register of all released batches intended for clinical trials, whilst they will also ensure continuous development and improvement of the Standard Operating Procedures related to the QP release process.

The Person

The Qualified Person will ideally be an industrial pharmacist with training and experience as a QP.  A QP listed in Belgium is required.  Excellent knowledge of EU GMP and EU clinical trial legislation and regulations is required whilst the ability to act as liaison with other Divisions where necessary (i.e. Clinical Supplies, QA, Clinical Operations, etc) is also essential

Key Words

Qualified Person, QP, Quality Assurance, QA, CRO, Clinical Research, Clinical Trials, CRO, Pharmaceutical, GMP, Career, Research, Job, Recruitment, Europe, Belgium, Brussels

For more information and to apply for this position, please contact Flame Pharma today on 0800 085 0858.