Quality Consultant

Our client, a global biotechnology company that employs over 20,000 people across the world, is looking to hire a Quality Consultant. The company specialise in creating breakthrough therapies for rare diseases, and works to produce an innovative pipeline across their key therapy areas.

In relation to all wholesale Authorisations in the United Kingdom; the Quality Consultant will have responsibility for ensuring that a quality management system is maintained in accordance with the Guidelines on Good Distribution Practice for medicinal product for human use (2013/C 343/01); Quality Assurance activities for UK assure implementation, maintenance and advancement of a systematic and efficient local quality assurance system according to applicable local requirement and relevant global requirements.

Job Responsibilities:

• Supporting initial and continuous training programmes are implemented and maintained;
• Coordinating and promptly performing any recall operations for medicinal products;
• Ensuring that relevant customer complaints are dealt with effectively;
• Ensuring that suppliers and customers are approved;
• Ensuring that any additional requirements imposed on certain products by national law are adhered to
• To write, review SOPs as required
• Reviewing and advising upon the company's standard operating procedures in relation to the operation of the license
• Support audit of the quality system on a regular basis, tracking and assisting in the closure of internal self-inspections, corporate audits and External Audits
• Implementation, execution and administration of CAPA's as required
• Ensure that accurate records, as required by the individual elements of the QMS, are kept and maintained in a secure manner
• Assist the Supply Chain Organisation to ensure continuity of supply is maintained.
• Support the execution of product launches and expansions in the UK
• Support on going integration projects at Shire associated with Distribution and Supply
• Monitoring and providing quality KPIs for the country or country cluster as required
• Ensure appropriate notification to MHRA for products in scope of OCABR process and appropriate tracking of their release are in line with appropriate timelines.
• Ensure inspection readiness in market
• Support to Quality Lead and other RPs within the cluster
• As an active member of Global QA Community, contribute to develop and strengthen global quality management systems, and provide flexible support to business both at the country level and global level.
• Providing any other duties or giving such other advice properly under the terms of the License and Guidelines on Good Distribution Practice for medicinal product for human use

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Caleb Mensah on +44 203 854 1080 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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