Quality Assurance & Regulatory Compliance Officer | Koropi, Greece
Boehringer Ingelheim
Koropi, Athens, GR
πριν από 6 μέρες

Join our Team!

Are youlooking for a great new opportunityto make the next step in your career within the Pharmaceutical Industry? Wouldyou like to join a very enthusiastic and energetic team?

Then this challenge isfor you!

We are looking for a Quality Assurance (QA) & Regulatory Compliance Officer for our Greek Production site, where we supply the global market with solid pharmaceuticals.

This position is located in Koropi (Greece) and you will report directly to the local QA Regulatory Compliance Manager.

Your daily challenges :

  • Prepare and maintain of CMC documentation for submissions of Boehringer Ingelheim’s worldwide sites (based on international pharmaceutical requirements)
  • Participate in global meetings to align with all relevant stakeholders (e.g. Regulatory Affairs, CMC experts) on adequate content and timing of required CMC documentation for changes
  • Issuance and follow up of change control for proposed changes worldwide
  • Work on product renewals and deficiency letters
  • Support business partners in regulatory topics
  • Collect GMP documentation packages for site accreditations
  • Requirements :

  • At least a Bachelor's degree in Engineering, Chemistry, Pharmaceutics or other Natural sciences
  • A minimum of 2 years of working experience in Quality Organization in the pharmaceutical industry in a Manufacturing environment
  • Excellent command of the Greek and English language
  • Working experience as a Quality Control Analyst and / or in Compliance / Pharmaceutical Process Technology Area is a benefit
  • Profound knowledge of regulatory guidelines with regards to the CMC part of the CTD (e.g. ICH, EMA, FDA guidelines)
  • Precise working and documentation style
  • Excellent interpersonal skills as well as ability to work in multi-cultural teams
  • Ability to discuss and solve issues together with other business units
  • Capable of working in a fast-paced changing environment, prioritizing multiple tasks to meet deadlines
  • Please note that only resumes in English will beconsidered.

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