About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
The Thermo Fisher Scientific HPLC business has been setting decisive and innovative trends for many years in the development, manufacturing and marketing of instruments and software for High-Performance Liquid Chromatography (HPLC). The expertise of our highly qualified staff contributes significantly to our economic success, enabling us to continuously expand our site in Germering near Munich.
For the support of our Team we are searching for a
Senior Quality Assurance Specialist - Software (f/m)
- Assume Quality Assurance role in SDLC processes and support to conduct reviews and releases.
- Preform root cause analysis and corrective action for product and process related non-conformances.
- In a timely manner analyze failure, corrective and preventive action.
- Proactively drive product and process improvement activities using PPI.
- Assist in maintaining the quality management system and manage tooling required to host QMS.
- Support the functions to ensure that products and processes comply with the relevant requirement.
- Execute (or assist with) other any other QM processes listed on QM System.
- Assist other functions ensuring QMS is up to date and relevant to business needs.
- Support with customer audits, ISO 9001 audits and conduct internal audits and supplier audits.
- Manage actions from all audits through to implementation and closure.
- 3- 5 years Quality Assurance experience in a pharmaceutical aware or related environment.
- Degree in computing, science or related discipline.
- Strong capabilities and knowledge in software development (requirement specification, code implementation and testing) as well as agile development.
- Basic experience of process design and improvement.
- Excellent working experience with IS0 9001 and basic knowledge of GxP regulations, GAMP 5 and 21 CFR Part 11.
- Computing skills including applications (MS Office, Visio, Subversion, Jira, SharePoint, TFS, etc).
- Excellent oral and written communication skills.
- Great influencing and negotiation skills.
- Ability to work independently or in a group setting.
- Auditor training
- Up to 25% Travel.
- Employment within an innovative, growth-oriented organization
- Outstanding career and development prospects
- Company pension scheme and other fringe benefits
- Exciting company culture which stands for integrity, intensity, involvement and innovation
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