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UDLØBET

Thermo Fisher Scientific

Sr. Technical Quality Microbiologist

Fuldtid

Permanent

Kamstrupvej 90, 4000 Roskilde, Danmark

SE PÅ KORT
ID: 2669628
|
Indrykket for 54 dage siden
:

  • Lead QA activities to optimise documentation for sterilization and surface modification
  • Support development and maintenance of test-methods, sampling plans, equipment, protocols, instructions etc. using statistical techniques to ensure compliance with regulatory requirements and relevant standards
  • Participate in validation and qualification of software, processes, test methods at our in-house gamma irradiation plant according to international sterilization standards
  • Participating and driving of projects with focus on quality improvements or quality documentation shelf-life testing, process improvements lean and practical process improvements PPI
  • Conduct and support root cause analysis during complaint handling, CAPA and NCM/OOS
  • Training of other employees at the site, in relation to quality - biology related issues ensuring that we can improve the level of knowledge in general at our site.
  • What will you need/what are we looking for?

    Ideal candidates will have some degree of knowledge of regulation such as ISO 11607, ISO 11137, GMP/GDP, 21CFR820, relevant ISO management systems and risk management systems.

    Experience in working in laboratories in either medical-devise or the pharma business or at suppliers to said business types. This could cover working with single use device and sterilization processes such as Gamma / E-beam /autoclaves.

    A candidate with a Bachelor’s Degree in micro-biology (or equivalent experience). And your post graduate training may cover production relevant areas such as lean/PPI, systematic problem solving, project management and good documentation praxis.

    You can inspire and motivate a cross functional team as project leader to achive your goals and have good communication skills both in Danish and English.

    Traveling may be required up 10 %.

    What are the benefits?

    We are a Fortune 500 company and maintain a pay-for-performance culture. We provide an extensive onboarding program and continued training throughout your career. Access to the most important scientific research laboratories in the organisation. We offer flexible work arrangements and many personal growth opportunities within a multifaceted organization.

  • Excellent basic salary plus bonus, Private healthcare, and a good cantina on site,
  • Thermo Fisher Scientific offers employment within 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.
  • At the local site there will be possibility to use a newly established gym. And we have a well functioning employee club arranging many social activities.

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