Thermo Fisher Scientific Hiring for Software Quality Assurance Engineer – Pharma background Job at United Kingdom Full Time

When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale! You’ll do important work in helping to build software systems and products that help governments, hospitals, and laboratories around the world. You will support the development & testing teams to achieve compliance for software product development across all aspects of the Software Development Life Cycle. Your knowledge of compliance and regulatory guidance (ISO27001, SOC2, EU GDPR, 21CFR Part 11, Eudralex Volume 4 Annex 11, ISPE GAMP® 5) will propel our collective success in delivering software systems in a complex regulatory environment. Your experience with quality management system and software product development will help to enable the success of software engineering, systems, and product teams across the globe.

What will you do?

• Provide daily support to the development and commercial operations, including software validation packages, product monitoring, risk assessment and CAPA and problem investigations.
• Ensure Software development design control, verification/validation is in compliance with applicable QMS and regulations (e.g ISO 27001, USFDA regulations (e.g. 21CFR Part 11), Eudralex Volume 4 Annex 11, ISO27001, SOC2, EU GDPR, among others)
• Represent Quality Assurance in sprint planning, reviews, retrospectives, release planning, demos and other Scrum-related activities
• Develop and implement appropriate product quality/process improvement strategies with guidance from multi-functional team based on risks and opportunities – e.g. continuously improve Software Development Life Cycle processes with the multi-functional team
• Work closely with Software development team, Software testing team and product owners to increase the reliability of the software via improving test automation infrastructure/test coverage and standard processes to guarantee a quality user experience to our customers.
• Responsible for the qualification of software vendors and service providers – verification/validation
• Support the Quality Management System – e.g. quality plans/initiatives, change control/management, CAPAs, Supplier management, training, and audit program
• Participate as a Quality resource/facilitator for audit programs including internal routine audits and external audits (e.g. ISO, Customer, etc.). Responsible to support the maintenance of the necessary multi-site certification by participating in Audits (for e.g. but not limited to ISO 9001, ISO 27001)
• Acts as the Quality representative of the Product related CAPA review board (CRB), supports the organization to perform Root cause analysis and corrective/preventive action review
• Engage in quality initiatives to continuously elevate the quality culture and drive process improvements, support quality metrics and reporting for management reviews

Who do we look for:

• Proven experience working in regulated laboratory environment – suitable for candidate’s with various education background (biology, chemistry, biomedicine etc.)
• Knowledge in regulations such as ISO9001, ISO27001 and 21CFR part 11
• Excellent understanding of software lifecycle
• Strong written and oral communication skills in English
• Knowledge of the following .NET and JAVA would be a plus
• Experience working with Azure DevOps dashboards & Power BI is welcomed
• Enjoys working independently and as part of a team, adaptability, diligent and positive approach

How do we motivate you:

• Employment with an innovative organization with exciting and fulfilling work
• Annual bonus
• Flexible working schedule, full-remote job
• Outstanding career and development prospects
• Company stocks program
• Exciting company spirit which stands for integrity, intensity, involvement and innovation
• The opportunity to work with a truly global organization
• benefits can vary based on the country

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.