d) at Thermo Fisher Scientific

Dreieich, Hesse, Germany

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Medical Devices, ManufacturingIndustries

Requirements

Bachelor’s degree level or equivalent experience
Confirmed experience of minimum 3-5 years as a Lead auditor including Supplier qualification
Experience/knowledge of EU GMP and GLP, ISO 9001, ISO 13485, ISO 14001 (and ISO 17025)
Knowledge/experience of ISO 17025 would be an asset
Proficient in German and English
The candidate must be independent and self-sufficient
Willing to travel up to 80%, mostly in Germany and Europe and occasionally outside of Europe

Responsibilities

Coordinate and lead supplier audits, ensuring audits are completed on schedule as part of supplier qualification and control program
Handle and lead internal audits of the organization sites as appropriate and on schedule to seek and/or maintain certifications: ISO9001, ISO13485, ISO14001, ISO17025
Report audit results and participate in Supplier Corrective Action establishment and follow up
Participate in the Global IES SCAR committee
Support European Supplier Quality management activities
Support resolution of non-conformities related to supplier management and/or internal audits
Mentor internal auditors to develop and maintain efficiency of internal audit program
Assist with Quality initiatives of the European quality team and worldwide team
Support Enterprise Service team as the need arises
Supported assurance and compliance asset management account activities including approval of the GMP approved supplier list
Maintain the customer-centric quality environment, specific to the asset management program that meets the quality requirements and it is compatible with the IES European QMS and the quality management system in Dreieich site
Other duties as assigned by acting manager as vital

Skills

Key technologies and capabilities for this role

Supplier AuditsInternal AuditsISO9001ISO13485ISO14001ISO17025Corrective ActionsSCARSupplier Quality ManagementNon-ConformitiesQuality CertificationsAudit CoordinationMentoring Auditors

Questions & Answers

Common questions about this position

What is the location and work arrangement for this position?

The position is located in Dreieich, Germany, with Home Office options.

What experience is required for this role?

Candidates need a Bachelor’s degree or equivalent, 3-5 years as a Lead auditor including Supplier qualification, and experience with EU GMP, GLP, ISO 9001, ISO 13485, and ISO 14001.

What languages are required?

Proficiency in German and English is required.

How much travel is involved in this role?

The role requires willingness to travel up to 80%, mostly in Germany and Europe, and occasionally outside of Europe.

What benefits does Thermo Fisher Scientific offer?

They offer employment with an innovative organization, outstanding career and development prospects, company pension scheme, other fringe benefits, and an exciting company culture emphasizing integrity, intensity, involvement, and innovation.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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