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, has deep 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.

　　Key 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.

　　Lead 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

　　Qualifications:

　　Education:

　　Degree (Diploma or Master) in Life Sciences (Biology, Chemistry, etc.) or Engineering.Experience:

　　At least 3 years of Quality experience in pharmaceutical.

　　Experience in Quality Management System.

　　Experience in biologics and aseptic training.

　　Experience in Deviation, Change Control, CAPA management.

　　Knowledge in Audit / inspections.

　　Proficiencies:

　　Practical knowledge in cGMP and Regulatory Compliance.

　　Effective Systematical Thinking and Communication ability.

　　Good Coordination and Teamwork.

　　Effective execution and result driving.

　　Good at Problem solving and Quality Risk Management knowledge and Tool application.

　　Continuous improvement attitude.

　　Languages:

　　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 (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.

　　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.