Quality Assurance Specialist

3 days ago


Winsford, Cheshire, United Kingdom Advanced Medical Solutions Full time
About the Role
We are seeking a highly skilled Quality Assurance Specialist - CSV to join our team in Winsford. In this role, you will be responsible for supporting the validation and revalidation of software systems and applications, ensuring these systems are compliant with applicable regulations such as GAMP, 21 CFR Part 11, and ISO 13485.

You will conduct and document risk assessments for software systems to identify and mitigate potential compliance issues, monitor and manage change control processes related to software systems, and plan and execute periodic reviews of computerised systems to ensure continued validation and adherence to regulatory requirements.

The ideal candidate will have a strong understanding of Quality System Regulations and ISO quality requirements, as well as experience with software validation standards, including GAMP and 21 CFR Part 11.

This is an excellent opportunity to work with a leading medical device company and contribute to the development of quality strategies, including harmonisation of computerised systems and related validation processes.

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