Company: Entrust Resourcing Solutions
Reference: MT 107
Closing Date: 10 Nov 16
Type: Full Time
Salary (£): 60,000 - 80,000
Entrust people are supporting a clinical development company who are going through a large growth phase in terms of organic contract wins and acquisition, our client is looking to hire a QP.
Entrust People are search and resourcing practice dedicated to the life sciences sector throughout the EU, we are currently supporting a mid sized clinical development company based in South Wales with the identification and hire of a Qualified Person (QP) who can work alongside the lead QP to deputise and have responsibility for the quality of IMP Manufactured, assembled or imported at our clients site and to provide expert opinion regarding the GMP Quality system.
To organise, advise or assist in or undertake, any or all of the following:-
?To advise upon the GMP Quality System at Site.
?To approve deviations / laboratory investigations.
?To approve Change Controls.
?To lead external GMP auditing programmes.
?To ensure Investigational Medicinal Products are manufactured/assembled and/or imported and released in accordance with directive 2001/20/EC Article 13.3 and in accordance with GMP, Clients MIA(IMP) and the information submitted to the regulatory authorities within the CTA.
?To review SOPs in this area as appropriate.
?To review, comment and advise on study protocols, manufacturing capabilities and technical agreements.
?To maintain an awareness of developments in the field of GMP which may impact upon pharmaceutical research.
?To discuss and liaise with clients and potential clients regarding formulation, stability testing, regulatory aspects, study design, feasibility, protocols and time frames.
?To be familiar with and work to all relevant Standard Operating Procedures in force.
?To conduct all work to Good Practice standards applicable.
for a confidential discussion or further information surrounding this role please contact Austin@entrustpeople.co.uk or alternatively contact 01224 907993
Keywords: Qualified Person, QP, GMP, Pharmaceutical research, Quality System, IMP, clinical development, South Wales, pharmacist, pharmacy
61 Dock Street Dundee Scotland DD1 3DU
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