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Permanent Positions

QA Associate
London, London

QA Associate, CVS

Permanent

£30,000 – £38,000

 

We have an amazing opportunity for a QA Associate to join our clients state of the art manufacturing facility in central London.

Our client is a clinical-stage gene therapy company who focuses on developing treatments for patients living with serious diseases, specifically diseases of the eye, salivary gland and central nervous system.

 

Major Activities

  • Support computer systems projects led by the QA Specialist, IT & CSV such as establishing system design requirements, executing test scripts, summarising validation activities and defining supporting procedures
  • Develop and deliver robust training programmes for system users
  • Maintain user access for each system
  • Maintain a relationship with the IT department and troubleshoot system issues
  • Identify and investigate potential system changes
  • Author and update procedures and validation documentation relating to CSV
  • Support computer system validation & re-validation activities, including risk assessments
  • Support periodic system reviews for implemented systems and provide metrics for system performance

 

Key Performance Indicators

  • GxP systems are maintained in a validated state
  • GxP system users are appropriately trained on implemented systems
  • Internal technical support calls for GxP system are handled in a timely manner

 

Job Responsibilities

  • Ensuring that your work complies with GMP, Data Integrity and Good Documentation Practice (GDP)
  • Responsible for ensuring that any GMP documentation assigned to me e.g. Issues, CAPAs, Maintain GxP systems in compliance with EU, GAMP and FDA GxP requirements
  • Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state

 

Job Background

  • Educated to degree level in Human Health, Sciences or equivalent
  • 3 years experience working in a GxP environment with a focus on IT compliance and CSV
  • IT literate with experience maintaining GxP IT systems
  • Knowledge of GxP regulations and guidelines relating to computer systems

 

Our client truly values their staff and offers a range of great company benefits! They also offer amazing opportunities for progression.

Salary: £30,000 - £38,000
Date Posted: 19/10/2022
  • S3Science is an equal opportunities employer: our recruitment process is fair, objective and open.

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