Job Information
ThermoFisher Scientific Senior Scientist QA Systems & Compliance in Lengnau, Switzerland
Job Description
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 expert for multiple system elements, 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.
Key Responsibilities:
Oversees, manages and handles material introduction processes and supplier qualification processes on site
Coordinates site inspection readiness activities to ensure site is ready for both client and regulatory audits at all times
Participates in hosting client and regulatory audits, responsible for timely and effective execution of external audit commitments
Monitors local regulation updates, coordinates gap analysis and comments feedback at site level, ensures site practice meets regulation requirements
Responsible for local quality agreement process with customers, suppliers, service providers
Leads the site Quality Management Review process, collects quality data, analyses compliance performance trends, is able to find opportunities for continues improvement
Administers site Quality Risk Management system, maintains site Quality Risk Register, ensuring Quality risk could be identified and appropriate mitigated
Participates in cross-functional teams on continuous improvement projects to further enhance site quality performance and client experience
Engages in quality initiatives to continuously elevate the quality culture
Qualifications:
Degree (Diploma or Master) in Life Sciences (Chemical/Biochemical...), Engineering or Pharma related Scientific area
At least 3 years of Quality experience in pharmaceutical industry
Experience performing audits, professional Auditor Certification preferred but not required
Strong cGMP knowledge standards focusing on supplier qualification process, quality risk management, deviation, change control and CAPA management
Experience with QRM tools such as FMEA and Quality Risk Register
Practical knowledge in GMPs and Regulatory Compliance
Strong interpersonal and communications skills
Proficient in using English as working language at listening, speaking, writing and Proficient in Office application
Ability to collaborate and work with other team members in a team-based environment
Proficiency in English, German is a plus
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 (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . 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.
Apply today! http://jobs.thermofisher.com
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.
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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.