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Compliance Engineer (f / m / d)

Thermo Fisher ScientificRheinfelden, Germany

Our Mission is to enable our customers to make the world healthier, cleaner and safer.Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasin...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen

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Compliance Engineer (f / m / d)

Thermo Fisher ScientificRheinfelden, Germany

Vor 30+ Tagen

Stellenbeschreibung

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Fisher Clinical Services GmbH is a subsidiary of Thermo Fisher Scientific Inc. and is a market leader in Clinical Supply Chain Management Services and Clinical Supplies for patients worldwide.

You can find out more about our location in Weil am Rhein and Rheinfelden here :

For the support of our team we are looking for you as

A day in the Life

Create and update existing standard operating procedure (SOPs)
Create qualification, re-assessment and Re / -mapping documents
Prepare and execute Re / -Mapping as well as the initial qualification and requalification of rooms and devices
Conduct testing, manage compliance assessments and oversee creation of deviations, investigations, and impact assessments to meet regulatory standards for three sites
Participate and represent facility department in external and internal audits, including responsibility for the execution of the audit´s findings
Act as point of contact for day-to-day quality issues
Work closely with other departments and customers in resolution of all quality issues
Perform software periodic review
Monitor, track and maintain records of all facility assets, equipment and systems by using the IBM Maximo asset

Keys to Success

Education

Bachelor's or master´s Degree in Engineering or Life Science

Experience

A minimum of 2 years working experience in pharmaceutical or related industry

Highly knowledgeable in cGMP and regulatory requirements, including 21 CFR Part 11 compliance

Know-how of qualification and mapping requirements according to cGMP regulations

A good understanding of Quality and documentation tools (Trackwise, eDMS)

Knowledge, Skills, Abilities

Effective verbal and written communication skills in German and English

Able to work collaboratively with others to form strong positive working relationships with colleagues, clients and contractors

Ability to work on own initiative and seek assistance when required

Ability to organise and prioritise workload to ensure that timescales are met

Ability to logically fault finds efficiently

High level of attention to detail and note taking

Demonstrate pride in work, through accurate timely delivery

Confident handling of quality systems such as deviations, change controls and CAPA

Strong analytical and problem-solving skills, with experience in multi-disciplinary environments

What we offer

Employment with an innovative, future-oriented organization

Outstanding career and development prospects

Company pension scheme and other fringe benefits

Exciting company culture which stands for integrity, intensity, involvement and innovation