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Bachelor Biologist, Biotechnologist, Biochemist as Quality Management Assistant, Regulatory Affairs Assistant – Multiplex Real Time PCR, RT-PCR (f/m)

Workscope: Quality Management

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Fast-track Diagnostics (FTD) Ltd develops and commercializes worldwide multiplex real time PCR (RT-PCR) assays to detect a wide range of viruses, bacteria, fungi and parasites. We are 13485 certified with most tests having a CE certificate. Our kits are used in all size labs, in the public and private sector. In the last years, FTD created a global distributor network that serves many countries worldwide. Quality, innovation and excellent customer support are our key objectives. We offer a job in an international, high qualified team.

Currently, we are looking to recruit an

Quality management and regulatory affairs assistant (f/m)
Full time.

Jobdescription
The post-holder will assist the quality management and quality control department in various tasks such as updating and generating various documentation in accordance with different normative and regulatory requirements. You will support various customers in the registration purpose of our products in various countries.

Key responsibilities
  • Work as a member in the quality management and quality control department
  • Support the QM and QC team in the tasks of generating and updating all relevant documentation (SOP, process instructions, manuals, ...) according to the ISO 13485 and the applicable regulatory requirements
  • You assist the QM department to prepare the necessary documents for registration purpose based on regional regulatory legislations and guidance
  • You assist the QM department in the establishing and maintaining technical files
  • Plan projects and act as an interim person between different departments
 
Your profile
  • Bachelor degree
  • Good understanding and knowledge of ISO 13485, FDA regulations, IVD 98/79/CE (other regulations would be considered as a plus)
  • Experience in RT-PCR
  • Good knowledge of MS office
  • Fluent in English both writing and speaking, any other language is considered as an advantage
  • High flexibility
  • Communication in a clear, concise and timely manner
If you feel that our job profile matches your qualifications and personality, please do not hesitate and send us your application in English, including CV, covering letter and your expected salary by  email to the following address:

Fast-track Diagnostics
HR/ Recruiting & Skill Management
Mrs. Elisabeth Chactoura
4354 Esch-sur-Alzette
Luxembourg
e-mail: Elisabeth.chactoura@fast-trackdiagnostics.com

For more information please visit our web site: www.fast-trackdiagnostics.com

Contact detail


How to apply:
by email
Send application to
 Elisabeth CHACTOURA

email: Elisabeth.chactoura@fast-trackdiagnostics.com

Job profile


Working hours
Full-Time
Contract duration
Permanent
Type of job
Specialist
Work experience
job experience is not required
Region
Luxembourg
Working place
4354 Esch s/ Alzette
Area of expertise
Biology & Life Sciences, Pharmaceutics, Human medicine, Healthcare & Public Health, Biotechnology
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