Reference
QAMANLON
Type
Permanent
Location
London
Salary
£60k - £70k per annum
Category
Operations
Sector
Pharmaceuticals / Biotechnology / FMCG

About this role

Northreach is partnering with a fast growing influencing CGT organisation specialise in developing novel treatment for inflammatory disease. In this role you will be responsible to developing the QMS for GMP production of clinical trials batches. London base.

KEY RESPONSIBILITIES

  • Assist in the development of PQS including establishing an eQMS
  • Perform routine QA duties to ensure manufacturing and testing activities comply with the local GMP facility processes where products are manufactured
  • Provide quality support to ensure starting materials are procured, tested and imported as required according to UK HTA requirements
  • Manage and monitor the following elements of the PQS relating to manufacture of cellular therapies including ;
    • document control system
    • change controls
    • corrective and preventative actions (CAPA)
    • deviation & OOS reporting
    • quality risk management
    • qualification & validation
    • internal audits
    • vendor qualification
    • batch record review prior to QP release
    • product specification files for ATIMP’s
  • Draft, review and approve Quality and GxP related documentation
  • Trend and report quality performance metrics from the PQS
  • Inform Head of Quality and Senior Management of significant quality related matters or risks that could impact patient safety, product quality, product release or regulatory compliance
  • Provide Quality support for R&D processes in state of the art R&D laboratories to ensure best laboratory and data integrity practices
  • The role may need to provide general support for quality related clinical operations under GCP
  • Organize training of quality system and deliver basic GMP training
  • Promote quality culture and one of continuous improvement within team

THE IDEAL CANDIDATE

  • Min 5+ years experience in GMP manufacturing environment (in particular small scale e.g. ATMP’s, clinical trials or individualised patient products is desired)
  • Min 3+ years experience in a Quality Assurance related role
  • University degree in a biological science, chemistry or equivalent
  • Experience in providing scientifically sound, risk based and pragmatic quality advice to manufacturing and quality control functions
  • Extensive experience writing and reviewing GxP documents (including SOP’s, qualification/validation reports and batch records prior to QP review) to ensure good documentation, data integrity, essential GxP, quality and regulatory requirements are met.
  • Demonstrated experience in developing a PQS especially involving an eQMS
  • A good working knowledge of GMP relating to sterile production, cleanrooms, aseptic technique and hygienic requirements for sterile products
  • Exemplary attention to detail and record keeping demonstrating good documentation practices
  • Excellent interpersonal and English language communication skills (written and verbal)
  • Capable of managing a wide range of tasks, managing own time effectively and prioritising tasks accordingly
  • Experience of delivering high quality training and coaching to staff
  • Ability to work with integrity, to high ethical standards with an open minded pragmatic approach
  • Good working knowledge of using Microsoft office programs
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