Compliance Engineer (fmd)
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Job Location:
Rheinfelden - Germany
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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 100000 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
Compliance Engineer (f/m/d)
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 audits 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
- Bachelors or masters 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
If you are interested please apply online with your CV and Motivation Letter including possible start date and salary expectations.
At Thermo Fisher Scientific each one of our 100000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.
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 disability or any other legally protected status.
Apply today!
Agency notice!
Please note we are not interested in receiving unsolicited CVs from any personnel service providers. Should you choose to send us or upload any such candidate document they will not be acknowledged and will be deleted in line with our privacy policy.
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
