QA Specialist (GMP Manufacturing)

CK GROUP ,
Stevenage, Hertfordshire
More Details
Salary: £35000 - £45000 per annum

Overview

CK Group are recruiting for a QA Specialist (GMP Manufacturing) to join a multinational clinical-stage research company focused on the development and commercialisation of gene therapies for debilitating disorders based on a next-generation AAV gene therapy platform. This will be at their site based in Stevenage on a permanent basis. The Company: The organisation has a strong pipeline of gene therapy products with 2 ongoing clinical trials. They will provide you with promising and exciting research projects in an environment that strongly values your development. Their gene therapy treatment builds upon their own pioneering work and their proprietary AAV capsid. Location: This role is located in Stevenage, Hertfordshire. The site is easily commutable by both train and road having strong rail networks with London and being reachable from the M1, M25 and A1(M). The Role: Your main duties as Quality Assurance (QA) Specialist will be to: Provide GMP QA support to manufacturing operations including reviewing executed batch manufacturing records (BMRs) for compliance with GMP and QA approval of manufacturing PPM and calibration activities. Assist with internal audits of GMP manufacturing activities as required and participate in external audits as required Act as the primary point of QA contact all GMP deviations and change control assessments. Your Background: The ideal candidate for this role will have: Educated to degree level or above in a relevant biological/life science discipline. Significant experience in a Quality Assurance role in a GMP environment, ideally with experience of biologics manufacture. Excellent communication skills and attention to detail For more information or to apply for this QA Specialist position, please contact Mary Bolt on 01246 457729, quoting job ref 47881 It is essential that applicants hold entitlement to work in the UK

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