Quality Expert for Medical Devices/Combination Products for Allergopharma GmbH & Co.KG (all genders)

Posted 28 Mar 2019

Schleswig-Holstein - all, Schleswig-Holstein - Germany

Req Id 190170


A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

We are a dynamic growing, international pharmaceutical company headquartered in Reinbek near Hamburg. Within the global Merck KGaA, Darmstadt, Germany pharmaceutical, chemistry and life science group, we have with great success specialized in the development, manufacture and sale of preparations to diagnose and treat allergic diseases. We are amongst the leading pharmaceutical companies in the area of specific immunotherapy.

Your role: This position is responsible for Quality Assurance for all Medical Device activities. This includes close collaboration with all internal functions and external partners as well as CMOs. Also, you initiate and follow-up on OOS, deviations and complaint investigations. Your position involves set-up and maintenance of CAPAs as well as quality assessment of change control requests. Furthermore, you lead an participate at audits of internal organization, suppliers and CMOs. Supporting for preparation for authority inspections and participation at these as quality representative for the product comprises your area of responsibility.

Who you are:

  • University degree in natural or technical science, PhD desirable
  • Minimum 4 years of professional experience in in a GMP regulated pharmaceutical environment
  • Ideally Experience with Medical Devices/Combination Products
  • Proven knowledge of all relevant quality guidelines and regulations, QMS as well as other quality control systems
  • Advanced experience with authority inspections, preferentially with US FDA
  • Strong self-organized and proactive way of working, highly self-motivated and ability to work in complex and changing situations
  • Excellent communication skills in German and English language

What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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