Biotech QA Specialist - Hertfordshire
Jason Johal is recruiting for a Quality Assurance Specialist to join a multinational clinical-stage biopharmaceutical research company focused on the development and commercialisation of gene therapies for debilitating disorders based on a next-generation AAV gene therapy platform. This is a permanent role based in Hertfordshire (20 minutes North of London via train) and offers an excellent salary circa the £40,000 mark and a good benefits package.
The Company: The organisation has a strong reputation for their technical and strategic expertise within the biopharmaceutical therapy market across Europe and places a strong emphasis on innovation to make a difference to patients lives. Their gene therapy treatment builds upon their own pioneering work and their proprietary product which has already transformed the lives of patients by providing a safe, effective and reliable gene therapy.
The Role: This role will report to the Director Quality Assurance and will be responsible for ensuring compliance of their GMP and GCP activities. The successful candidate will play a key operational role in securing successful delivery of development programmes.
You will be responsible for the review and progress of Change Controls, Deviations, OOS reports and CAPAs and also the review and approval of Standard Operating Procedures. You will issue batch manufacturing records and labels to Production, release raw materials for use in manufacturing, review validation protocols and reports and coordinate batch manufacturing reviews. You will also maintain Product Specification File (PSF), manage Quality/ Technical Agreements with third parties, conduct internal audits to monitor procedural compliance and trend quality metrics.Your Background: Educated to degree level or equivalent in a biological or physical science you will have gained relevant experience in a Quality Assurance role in the Pharmaceutical/Biotec industry which will include, time in a GMP-regulated environment, ideally working with Investigational Medical Products (IMPs). You will require the ability to work in a small team in a dynamic environment and preferably will have experience working with biologics, preferably ATMPs. Any GCP QA experience would be advantageous as would familiarisation with electronic documentation systems.
This is an exciting opportunity to join a rapidly growing world-class multidisciplinary team, which is dedicated to the manufacture of novel, life changing gene therapy medicinal products.
For more information or to apply for this QA Specialist position, please contact Jason Johal on 01438 723 500 or firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. 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 45496 in all correspondence.