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Medical Device Change Control Expert (NOVJP00026786) (m/f)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Engineering, Design

Projektbeschreibung

REFERENCE NUMBER:

380125/29

MY DUTIES:

-Support roll out of new change control process including training of personnel on process and systems
-Work with team members across sites to ensure quality documentation meeting all regulatory requirements
-Follow up with team members regarding actions to understand and remove roadblocks in completing changes
-Review and report KPIs to ensure timelines of change control actions

MY QUALIFICATIONS:

-Master degree in Science/Engineering or Mechanical Engineering or University level engineering education
-Excellent skills in English language are required
-In-depth experience in a similar area
-Experience in DHF compilation, including Design Control process and other applicable regulatory, QA and GMP aspects
-Experience in managing medical device/combination product Change Controls
-Experience in DHF compilation, including Design Control process and other applicable regulatory, QA and GMP aspects
-Experience in pre-filled-syringe device development, from early phase activities up to commercialization and production scale-up
-Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive), ISO13485
-General understanding of pharmaceutical development, Human Factors Engineering and risk management

MY BENEFITS:

-Working experience at a global player in the pharmaceutical industry

PROJECT INFORMATION:

-Novartis in Basel

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Christina Ruhl

Reference number
380125/29

Contact
E-Mail: [email protected]

Projektdetails

  • Einsatzort:

    Basel Stadt, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 MM

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland