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.
As part of the QA systemsTeam of Fisher Clinical Services GmbH, Lengnau (LGN), the position holder is responsible oversee the compliance with laws, regulations, health authority expectations, and internal requirements in respect to Audits and Inspections.
Summarized Purpose:
Serves as subject matter expert to design, develop, deliver and improve products, programs, and services in order to optimize processes, behaviors, performance and audit readiness. Accountable for assigned initiatives aimed at supporting and/or ensuring quality operational delivery via efficient and effective processes, associated systems, training and communications. Interprets data on sophisticated issues, leads teams and makes good business decisions with support.
Key responsibilities:
- Proactively collaborates with initiative leads and management to prepare organize, coordinate, document and/or provide the development and delivery of department products and services to a globally dispersed, cross-functional audience in support of business outcomes and industry compliance requirements.
- Develops as trainer varied support materials, presentations, and/or tools to support department's remit and strategies.
- Proactively collaborates with initiative leads and management to develop, optimize and improve processes, associated systems/applications, training and communications.
- Oversees, manages and handles the training process at the site
- May review, assess and update procedural documents for overall compliance with current processes.
- Coordinates inspection readiness program on Lengnau site with proactive strategy managed by a proper governance
- Internal Audit process (Lead auditor role)
- Participate of ensuring compliance on the job (shopfloor walktrough)
- Support on material introduction qualification and supplier management
Keys to Success
Education and Experience:
Degree (Diploma or Master) in Life Sciences (Biology, Chemistry, etc.) or Engineering. Languages : German and English.
Minimum of 3 years experience in cGMP Quality Management, Systems development
Strong Knwoledge of cGMP including current knowledge of industry guidance documents and standards focusing on training system, document management system, self-inspection, deviation, change control and CAPA management.
Knowledge, Skills and Abilities:
- Thorough understanding of procedural document
- Strong understanding of process improvement fundamentals
- Proven investigative and analytical skills
- Strong negotiation skills
- Effective judgment, decision making, escalation, and risk leadership skills
- Strong interpersonal skills and problem solving ability
- Strong attention to detail
- Thorough understanding of regulatory guidelines and directives
- Strong creative and critical thinking skills
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
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 with PPD, part of 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
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