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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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

• This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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.