QA Operations Specialist
Our client is a privately owned, fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar products. Operating from a new a state-of-the-art manufacturing facility in Reykjavik, Iceland, they are specialists in biosimilar product creation working across the entire value chain from cell line development to commercial manufacturing.
They are currently seeking a Quality Operations Specialist with a background in biologics Drug Substance manufacturing to join them on a full-time permanent basis. The successful candidate will work as the QA contact person within upstream and downstream Drug Substance manufacturing at their cutting-edge facility. You will provide general QA expertise and support for drug substance including the investigations of Deviations/ OOS and QA approval of CAPAs. You will also support and approve Change Control records, contribute to the preparation of audits and inspections, participate in CAPAs resolution, review and approval of SOPs, QA review and approval of product specifications/ Master Batch Records and QA review of executed batch records.
The successful candidate will be degree educated with significant experience of working within a biologics Drug Substance manufacturing environment. It is essential that the incumbent has several years' experience within an upstream (USP) or downstream (DSP) biologics manufacturing environment. Our client will consider those with a proven track record in Quality Operations but may also consider talented individuals with a manufacturing background wishing to make a move into QA providing they have a track record within biological GMP environment in deviation investigation, batch record reviewing etc.
This is an exciting opportunity to join one of the fastest growing biologics companies in the industry today who promote best-in-class quality standards and techniques. You will become part of an organisation committed to supporting the provision of life changing treatments and medicines to patients across the world. You will gain rich and varied experience in a ground-breaking operation whilst also getting the opportunity to explore one of the most fascinating countries on the planet offering high standards of living in a beautiful environment. Our client has a demonstrated track record of promoting from within and rapidly advancing the careers of talented individuals within the organisation. For the talented individuals who are successful in their application our client will offer full support with relocation and integration into the Icelandic culture.
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 contact Steven Fuller at +44 203 854 2630 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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