Job Ref: 214722354

Date: 2021-09-22 15:17:03

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Hobson Prior are currently recruiting for a Qualified Person to join a fantastic pharmaceutical organisation who are a worldwide leader in clinical trials supply. This role will be on a permanent basis and located in Buckinghamshire.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

You will be responsible for the provision of GMP training.
You will be providing support to Business Development/Sales and Project.
Providing QP certification in compliance with regulatory requirements and if required, specific client technical agreements.
Providing QP GMP declarations, including on site audits if required, in support of importation activities.
To provide information and training on the QP roles and responsibilities to FBS personnel.
To maintain an up-to-date awareness of the regulatory issues affecting the clinical supplies process keeping relevant FBS colleagues informed where appropriate.
To provide technical advice and support in the preparation of Technical Agreements.
Support client and regulatory audits with QP input.
Prepare, maintain and deliver key performance indicators (KPIs) for all aspects of the quality system
To identify and correct all trends developing via KPI monitoring.
Review and ensure that labels for IMP are compliant.
Provide QP declarations for material to be used in clinical trials where necessary.
Certify each batch of IMP for use in human clinical trials. Requirements.
Eligible to act as a QP and RPi in accordance with EU Directive 2001/83/EC.Requirements:

The ideal candidate will be educated to a degree level within a life science subject.
Has a thorough understanding of Directive 2001/83/EC.
Strong understanding of the GMP and GDP Regulations.
Strong understanding of the German Pharmaceutical Licence obligations.
Good understanding of, The New Guidelines for Good Distribution Practice of medicinal products for human use (2013/C 343/01).Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy

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