Qualified Person, London

130000.00 - 160000.00 GBP Annual + GBP130000 - GBP160000/annum
28 Jul 2017
25 Aug 2017
Contract Type
Full Time
Jim Gleeson is recruiting for a permanent Qualified Person to join a very well backed global biosimilars company who are in the process of establishing their presence in Europe. The role will be based at their new offices in North London.

As Qualified Person you will hold responsibility for the release of investigational and medicinal parenteral biopharmaceuticals and act as the primary quality contact for regulatory agencies.

Key duties will include:
- Assurance that investigational and medicinal products are manufactured, tested, labelled, packed, released and certified for distribution in compliance with the approved authorizations, relevant guidelines and all applicable laws and regulations
- Assurance that products of insufficient or dubious quality, safety and / or efficacy are not distributed
- Acting as Lead Auditor for internal and third party audits
- Review of quality and regulatory documentation such as change controls, deviations, PQR / APR, annual stability and trending reports

As Qualified Person you will require the following:
- QP certification
- Extensive experience of acting as a QP for parenteral biopharmaceutical products
- Expert knowledge of GMP and GLP requirements
- An in-depth understanding of FDA and EMA standards and quality systems
- Audit, investigation and report writing skills
- Strong communication and interpersonal skills

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST39709 in all correspondence