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Qualified Person acc. § 15 Abs. 1 AMG (m/w/d)

  • Location: Darmstadt
  • Salary: negotiable per year
  • Job Type:Permanent

Posted 23 days ago

  • Sector: Pharmaceutical
  • Contact: Sebastian Gotzler
  • Contact Email: s.gotzler@sciproglobal.de
  • Start Date: asap
  • Expiry Date: 04 June 2022
  • Job Ref: RA_2022_18_1651754549

Qualified Person (m/f/x) | Personal Health Care

As team member of the Quality Operations department at this pharmaceutical production site, you will be responsible for the market release of medicinal products in accordance with § 15 Abs. 1 AMG. As a Qualified Person you will ensure the dossier compliant production of all medicinal products. You will be significantly involved in deviation management and change control as well as in customer complaints with regards to compliance with dossier conformity and GMP principles. You will work closely with the supplier qualification team in the qualification of new raw materials. You are also the central contact person for quality-related questions.

Your requirements as "Qualified Person (m/f/x)"?

  • University degree in pharmacy
  • Qualification as a Qualified Person and assumption of the function according to §15 AMG or willingness to appointed as Qualified Person
  • Experience working as a qualified person in the pharmaceutical industry
  • Good knowledge of national, European and international regulations for medicinal products
  • Very good IT skills (MS Office, etc.)
  • Very good knowledge of German and English
  • Team and communication skills, flexibility

Information about our client:

Our client was founded over 150 years ago and has developed into the world's leading consumer goods company with a portfolio including some of the most trusted brands on the market. Their product portfolio includes 60+ individual brands with one of them being "Personal Health Care", where this position will be located. The client is operating in more than 100 countries worldwide and has almost 100.000 employees.

I look forward to your application!