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QA Associate – Cell Therapy – London

QA Associate – Cell Therapy – London

A fantastic opportunity has arisen for a QA Associate – Cell Therapy to join an expanding clinical stage biotechnology company in London. As an organisation they are committed to developing next generation, patient specific therapies, bringing together strong expertise across cancer evolution, bioinformatics and cellular therapy.

You would play a key role in establishing, growing and maintaining the quality systems and processes for the whole organisation which has satellite sites in two other London locations. A hands-on approach is essential and it is expected that the successful candidate will work with the manufacturing and QC teams to implement and develop key documents and support of the clinical and regulatory departments in compliance with regulatory requirements and compliance with the company QMS.

Responsibilities
-Support the QMS ensuring activities conform with regulatory requirements
-Assist in routine QA duties and audits to ensure GxP & HTA compliance plus other regulatory requirements relating to manufacture and clinical trials for cellular therapies and ATIMPs including:

odocument control system
ochange controls
ocorrective and preventative actions (CAPA)
odeviation & out of specification (OOS) reporting
ocalibration and maintenance
oqualification & validation
ointernal audits
ovendor qualification including external audits as necessary
oDevelop and review Quality and GxP related documentation

-Assist in the management of Product Specification Files for ATIMP’s
-Support the Implementing and Maintaining of training records for the company and training structures and requirements as the company grows.
-Support the implementing of systems from a quality perspective to ensure ATIMP traceability and responsibility
-Ensuring efficient quality systems supporting logistical aspects product and sample transport and handling
-Advising in the preparation of validation protocols and reports and review of data generated in the execution of validation protocols.
-Working closely with the manufacturing and QC teams to establish key manufacturing documentation in line with a Contract Manufacturing Organisation’s own QM system

Essential experience
-3 years’ experience working in QA in a biopharmaceutical GMP environment.
-Experience in setting up and managing robust Quality Management systems ensure GxP compliance
-Good working knowledge of the tissues and cells directive
-Experience of working with contract manufacturing companies
-Technical knowledge of quality requirements for manufacturing processes and laboratory techniques
-English Language skills
-Good working knowledge of using Microsoft Office programs

Desired experience
-A working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP’s
-An understanding of GCP, GCLP, GDP and HTA requirements
-Experience of auditing key raw material suppliers as to GMP compliance.
-Experience in vendor and site audits
-Experience of training staff

Qualifications
-BSc or MSc in a biological subject

To find out more about this superb opportunity please contact myself, Lauren Gripton, of Paramount Recruitment on lgripton@pararecruit.com

Keywords- QA, quality assurance, quality, atmp, atmps. Advanced therapy medicinal products, cellular therapies, cell therapy, gene therapy, bsc, msc, gmp, manufacturing.

Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.

Job Reference: Lg44563_1542102275

Salary Currency: GBP

Salary per: Annum

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