- 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
- 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
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Senior Scientist QA Systems - Lengnau, Schweiz - Thermo Fisher Scientific
Beschreibung
:Qualifications:
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain . 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.
