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Specialist Quality Assurance (m/w/d) GMP regulated area

Referenz: 414779001900

on 05 August 2020
Stadt
Biberach
Vertragsart
Festanstellung

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 pharmaceutical Branche, located in Biberach an der Riß. Commencing immediately, on a temporary basis.

What you can do for us

  • Process external deviations and OOX results initiated by external partners (CMO, CL, Service Providers) in compliance with regulations and BI internal procedures.
  • Enter information about external deviations / OOX results in the database
  • Assess external deviations and coordinate the investigation and CAPA in alignment with the Team Member Quality as needed
  • Coordinate deviation / investigation related activities and present the results to the key personnel at BI
  • Support and advice functional departments during processing of deviations, investigations and CAPAs
  • Represent the interface between functional departments, pharmaceutical key personnel as well as subject matter experts and external partners
  • Contribute to the optimization and development of the process and the supporting IT system for Deviation / Investigation / CAPA Management
  • Present deviations during inspections
  • Generate KPIs, overviews and trend reports related to external deviations
  • Supports the qualification process of external service and material suppliers by contributing to the creation and maintenance of Quality Assurance Agreements and collection of documents and performing data entry in the corresponding electronic database

The skills that are needed

  • Bachelor or Master degree with focus on natural science (e.g. Pharmaceutics, Chemisty, Biology or Biotechnology) or Professional Training with several years of experience in the pharmaceutical industry in a GMP regulated area (e.g. Quality Assurance)
  • Several years of experience in the pharmaceutical industry in a GMP regulated area
  • Knowledge and hands-on experience gained in GMP regulated environments in pharmaceutical development

    or production or quality control or quality assurance for 3-4 years.

  • Experience in development and manufacture of pharmaceuticals, biopharmaceuticals or ATMPs would be beneficial
  • Knowledge of international regulatory guidelines (US, EU, ICH) and quality standards for human pharmaceuticals including respective development activities and data handling
  • Knowledge of quality and risk management tools would be beneficial
  • Well organized and structured working approach
  • Good communication and presentation skills
  • Fluency in written and spoken English and German.

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 Laura Mäntele

Bewerbung.FreiburgLS@modis.com

Modis GmbH

Life Science

Güterhallenstraße 4

79106 Freiburg

Phone +49 761 3890 8216

www.modis.com

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