Main purpose of the role:

Accountable for the Pharmaceutical Quality Department activities, relating to product support - used for the manufacture, packaging, testing, storage and distribution of investigational medicinal products, to comply with current GMP, Quality System and Corporate expectations and Industry Standards.

Accountable for implementing and maintaining the company's QMS and processes to support cost effective provision of product and services.

Accountable for liaising with the Product Creation Systems, Regulatory Affairs, Third Party Contractors, to ensure that schedules for the release and distribution of products are met.

Carry out legal duties of a Qualified Person (QP) as specified under EC directive 2001/83/EC as amended and 2001/20/EC.

To ensure compliance with the requirements of Annex 13 of the EU Guidance on GMP for clinical investigational medicinal products.

Qualifications, education and language requirements:

* Graduate with Life Science degree.
* Eligible to act as a Qualified Person.

Experience Required:

* Proven working knowledge and experience of Quality Assurance, Quality Systems, GMP and a basic understanding of manufacture, testing and packaging of pharmaceutical products.
* Extensive knowledge and understanding of EU clinical trial regulations.

Skills and Aptitude Required:

* Good technical and scientific judgement.
* Strong organisational skills
* Good communication skills.
* Developed presentation skills.
* Ability to interpret and translate GMP Guidelines.
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