Scientist, QA Systems
vor 7 Monaten
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
**Position Summary**: This position is expected to be QA Scientist for multiple system elements, has understanding in quality computerized systems, assist deployment of corporate policy at site, PQR and events management. Understand basic quality tool, find opportunity to improve the process proactively, provide mentorship to other departments for basic quality process and cooperate to complete job.
**Your Responsibilities**:
- Maintain QMS systems (e.g. TrackWise, eDMS, SFLMS etc.). Authors SOPs / Work Instructions related to QMS and ensure the SOP landscape operation readiness within LGN site
- Lead corporate standards gap assessment, ensure site practice follows regulatory requirements
- Lead the maintenance of document and record management system, supervise the effective execution of site document management requirements
- Responsible for maintenance of GMP training system, develop cross function training champion team, supervise and coordinate the effective implementation of site training and personnel qualification. Support the training lead and coordinate GMP training. Introduce, develop and improve site GMP readiness
- Support the annual product quality review
- Assist Practical Process Improvement (PPI) activities
- Supports the management and administration of Inspections and Audits at the site
- Complete any other related work assigned by company
**Your Qualifications**:
- Bachelor degree required, preferably in Biotechnology, scientific related field
- A minimum of 3 years of experience with previous experience in Quality Assurance, Quality Control environment, Analytical Lab Experience preferred
- Equivalent combinations of training and relevant work experience may be considered
- Previous experience in a cGMP environment
- Practical knowledge in cGMP
- Effective Systematical Thinking and Communication ability
- Good Coordination and Teamwork
- Effective execution and result driving
- Good at Problem solving
- Continuous improvement attitude
- Proficiency in German and English
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability** Access**:
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