Description
2 Exciting new Software Quality Assurance roles:My client is a leading Medical Devices company and they are seeking two Software Quality Assurance Engineers to join their expanding team.
It is an exciting time for this company who are highly successful in the market and offer an excellent work environment where you will be working alongside highly talented people.
The Software Quality Assurance Engineer will act as a SQA lead on software or automation projects, conduct verification and validation activities
QA & SQA Activities
- Responsible for ensuring that systems are in compliance with regulatory commitments, in-house requirements and cGMPs in regards to computerised systems.
- Investigation of software related deviations as part of quality team.
- Review of software related GMP critical documents, eg Requirement documents, software validation protocols, change controls and discrepancy reports.
- Participate in Software Process Improvement activities.
- Manage the software corrective action process
- Participate in requirements gathering
- Review of pre-delivery or vendor supplied information in regards to suitability to proceed with validation activities.
- Development of protocols, test scripts and associated support documentation
- Overview of the execution of software related protocols
Qualifications / Experience required:
- Third level qualification in a science, engineering or computing discipline.
- 5+ years experience in a GMP regulated environment or software quality role.
- Must be familiar with the regularoty requirements of the FDA and/or ISO
- Experience of executing validations in a cGMP manufacturing environment
- Experience of scientific report writing including such documents as SOPs, protocols, deviations, reports etc. is essential
This role is a 12 month fixed term contract based in Waterford with an excellent salary of EUR45,000 - EUR50,000. If you are interested in this position please contact
me, Derek Sheridan, on for more information and click apply now for immediate consideration
To find out more about Real please visit www.realstaffing.com
To find out more about Real please visit www.realstaffing.com