I am working on an exciting new opportunity with a cell and gene therapy software solutions provider based in Cardiff!

They are seeking an ambitious Senior QA Associate responsible for overseeing the QMS and helping with customer deployment projects.

This role will offer you:

· Your first role in the cell and gene therapy space!

· The chance to work for an international technology company.

· The opportunity to contribute to work that helps bring life-changing products to the market.

You will be responsible for:

· Writing, reviewing and approving SOPs and policies within the eQMS

· Reviewing and approving Validation documentation, test reports etc

· Being involved with Root Cause Analysis (RCA), CAPAs, deviations, change control etc

· Performing internal audits to ensure compliance

· Supporting with customer audits and CSV activities

You will bring the following:

· 3+ years’ experience in a regulated industry (pharma, med dev, IT, etc)

· eQMS experience

· ISO 9001:2015 or ISO 13485:2016 QMS experience

· Computer System Validation (CSV) experience for compliance with GAMP 5

· Internal auditing or lead auditor experience
 

If you're interested, GET IN TOUCH, by applying through this ad or sending your CV across to shola.sonagara@biotalent.com!