Senior GMP Manufacturing Associate (Cell Therapeutics)Based in HertfordshireCompetitive Salary + Package Do you have experience within GMP Cell Manufacturing?Would you like to work in a...
QA Manager - Cell Therapeutics
Based in London and Hertfordshire
Paying £55,000 - £70,000 + Excellent Benefits
Do you have significant experience of QA Activities from within a GMP Manufacturing environment?
Would you like to work for a leading Cell Therapeutics company with an enviable portfolio of products in clinical and pre-clinical development?
My client are a leading cellular theraputrutics company, employing leading scientists and Pharmaceutical / BioPharmaceutical professionals from around the world. They are committed to patients and providing them with life changing cell therapies. With their pipeline looking stronger than ever, they have a vision of becoming a market leader in cell therapy and are looking to strengthen their Quality team through the permanent appointment of a Quality Manager.
Acting as the company QA Manager across both manufacturing and pre-clinical research, you will support to manufacturing operations, manufacturing Cell therapy products for clinical use based within their GMP manufacturing suite. The job responsibilities include Quality support for process development work for new clinical trial products and review and approval of documents including batch records, SOPs and validation/qualification plans and reports. In addition to provide some general quality support to R&D activities and clinical laboratory testing to GCLP and for quality related clinical operations under GCP.
To be considered for the role you will need the following skills and experience;
- University degree (BSc, MSc or PhD) in a biological science, cell biology, pharmacy, chemistry or equivalent working experience
- Considerable experience working in a GMP environment (in particular small scale e.g. clinical trials or manufacturing individualised patient products.)
- Significant experience working in a Quality / QA related role
- Experience of writing and/or review of GxP documents (SOPs, qualification/ validation reports and batch records) to ensure good documentation practice and essential GxP, Quality and regulatory requirements are met
- A good working knowledge of GMP and of cleanrooms, aseptic technique and hygienic requirements for sterile products.
- Excellent interpersonal and communication skills (written and verbal)
- Highly self-motivated and able to motivate others
- Working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products and/or advanced therapy medicinal products (ATMPs) would be an advantage
KEY WORDS "Good Manufacturing Practice, Pharmaceutical, Biopharmaceutical, eQMS, Quality Management Systems, QMS, QA, Specials, Quality Assurance, Audits, Deviation, batch records, QA Manager, Quality Assurance Manager, Quality Manager, Lead Auditor, GCP, GMP, Clinical Trials, Pharmaceutical Development, GxP, IMP Manufacture, QC, Pharmaceutical Product Development, CAPA, SOP, advanced therapy medicinal products, ATMPs"
This is an excellent opportunity for an experienced QA Professional to join a leading Cell Therapeutics company.
Please apply online or call Neil Walton on 02030964706.