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Change Manager (m/f/d) CMC filing in part-time 50%

Referenz: 404060001900

on 27 April 2020
Stadt
Singen
Vertragsart
Befristet

The future belongs to those who drive innovation, inspire transformation and fuel collaboration. Our commitment is achieved by working together with our clients in combining the key technologies IT, Engineering and Life Sciences in order to develop innovative solutions for the future. We connect top companies with the sharpest minds in Life Science. All of them united by their burning passion to make use of their talents in order to master the challenges ahead. Are you one of them?

If so, you are what we are looking for as a co-worker for a project by one of our customers, a renowned company in the Pharma Branche located in Singen. Commencing immediately in part-time 50% on a temporary basis.

What you can do for us

  • You are in charge of the management of change control and CMC filing submissions (Chemistry, Manufacturing and Controls)
  • Responsible contact person for department stakeholders and CMOs (contract manufacturing organizations) concerning changes and CMC filings
  • You coordinate and execute change controls in the field of Quality
  • Renewals of registrations, notifications and change controls are being coordinated in cooperation with Regulatory Affairs
  • You write CMC documents (incl. Module 3 document sections)

The skills that are needed

  • You provide a degree in the field of Life Sciences (Pharmacy, Chemistry, Biology, Process Engineering or equivalent)
  • Several years of experience in the field of Project Management, Production or Quality Management
  • Experienced in writing CMC, ideally in eCTD Module 3
  • Good knowledge of regulatory requirements regarding manufacture of medicinal products
  • GMP knowledge
  • Result-oriented, structured working style as well as cultural awareness
  • Fluent skills in English

Why you are in the right place when working with us

We connect the right professionals with the right project, as we do by connecting you with our recruiting projects! Our path together begins with trying to comprehend your ambitions. We shall work together to help you achieve your career objective, by investing in your professional development and mentoring, and by coaching you throughout your career. Modis is a global leader in professional solutions and a dynamic brand with a global focus. We are pursuing ambitious goals in a key market. Our affiliation with Adecco Group opens up a wide array of career choices for you.

You can hardly wait to get to know us? Then a simple click will quickly connect you with us. Just click on "APPLY NOW“ to send us your application.

Your Contact

Frau Svenja Oschwald

Bewerbung.FreiburgLS@modis.com

Modis GmbH

Life Science

Güterhallenstraße 4

79106 Freiburg

Phone +49 761 3890 8216

www.modis.com

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