Functional head of quality control [12 AMWHV] (m|f|d)

Miltenyi Biotec

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profile Job Location:

Bergisch Gladbach - Germany

profile Monthly Salary: Not Disclosed
Posted on: 1 hour ago
Vacancies: 1 Vacancy

Job Summary

Your role

Together with the teams from manufacturing quality assurance and development you will create a dynamic GMP environment in which collaboration and innovation are practiced daily.

  • You ensure that all starting materials intermediate products and finished products are checked and released/blocked according to specifications and carry out the functional tasks of a head of quality control in accordance with 12 AMWHV
  • You ensure that the necessary test procedures are validated in the operational teams and that all necessary tests as part of development projects and release tests are carried out and documented in accordance with GMP.
  • You are responsible for qualifying equipment and validating computer-based systems
  • You are proactively involved in the continuous improvement and increase in efficiency of our processes create GMP-relevant SOPs and thereby always ensure our high quality standards for our therapeutic products.
  • You will be involved in self-inspections and audits by customers and monitoring authorities and will subsequently process open activities and anomalies

Qualifications :

Your profile

  • You have successfully completed your science studies.
  • You have already gained several years of professional experience in quality control of cell-based ATMPs and have extensive experience under GMP.
  • You have already worked as head of quality control in accordance with 12 AMWHV or fulfill the requirements to complete your training in this direction and are ready to take on this responsibility for ATMPs.
  • You have a strong understanding of analytical methods in the quality control of cell-based ATMPs such as flow cytometry qPCR analyses endotoxin tests and microbiological tests. 
  • You work in a structured prudent and solution-oriented manner - even in challenging situations - and are characterized by a high level of quality and responsibility and motivate your team to achieve top performance.
  • Due to the timely analysis required as part of CAR-T cell therapy you have a strong willingness to work both early in the morning and in the late afternoon or evening if necessary
  • Your English skills are fluent spoken and written so that you can move confidently in an international environment.
  • Skills in speaking reading and writing German are desired and are a plus

Additional Information :

What we offer

  • Diversity: International teams and cross-border intercultural communication
  • Room for creativity: Its the most clever solution that we always strive for
  • Health & Sport: We offer a wide range of corporate sports activities and health provision
  • Miltenyi University: A clever mind never stops learning take advantage of our in-house Training Academy

 

Diversity is the bedrock of our creativity.

Our mission: To innovate treatments and technologies and tackle the worlds most serious health challenges. And thats why we connect the dots across various disciplines linking different perspectives skills and abilities.

You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender sexual identity age ethnicity religion or disability.

Become part of our team and focus on pushing the borders of medicine.

 

Contact us

If you have the skills and qualifications for this position please use the link to send us your details (application letter curriculum vitae references and certificates). Please give us some idea of when you can start and the kind of salary you are looking for.


Remote Work :

No


Employment Type :

Full-time

Your roleTogether with the teams from manufacturing quality assurance and development you will create a dynamic GMP environment in which collaboration and innovation are practiced daily.You ensure that all starting materials intermediate products and finished products are checked and released/blocke...
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About Company

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For over 30 years, Miltenyi Biotec has been a major provider of products and services that drive biomedical research and boost cell and gene therapy. More than 4,700 employees in 23 countries combine excellence in research with innovative products to create cutting-edge solutions that ... View more

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