QA Associate - S3 Science S3 Science

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

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