Quality Assurance Auditor (m/f/d)


  • You will lead and participate in Quality compliance audits of internal and external facilities to identify weaknesses and deficiencies in the areas GMP and/ or Regulatory Compliance according to local, regional, and global regulations, guidances, and current expectations
  • You will maintain relationships with sites throughout Europe and Israel to be aware of their risks and support risk mitigation
  • Communication of Quality compliance audit risks
  • You will categorize Quality compliance audit observations as a basis for decision-making for Teva Corporate QA and the Qualified Persons, among others
  • You will communicate Quality compliance risk derived from internal and external facilities to Global Quality Compliance management
  • Mitigation of risk
  • You will work with internal and external sites to define appropriate CAPA plans to reconcile observed deficiencies in Quality systems and monitor their implementation
  • You will provide support to sites who are preparing for and responding to inspectional observations from various regulatory authorities
  • Training
  • You will take part internal and external training events and seminars to stay up to date with the latest developments in the national and
  • You have at least 5 - 7 years professional experience in the chemical pharmaceutical industry with diverse exposure and experience performing audits
  • You have a Bachelor's degree in a science subject, preferably Chemistry or Pharmacy or a comparable qualification (for instance scientific vocational training with professional experience)
  • You have achieved certification as a Quality auditor
  • You bring a solid knowledge of the relevant national and international regulations (EU GMP rules, WHQ guidelines, ICFI-guidelines, US FDA guidelines, ISQ guidelines)
  • You have developed knowledge of many different chemical, biochemical and pharmaceutical manufacturing processes
  • You offer fluent written and spoken communication in English as a minimum with some proficiency in French as desirable
  • You are capable of traveling up to 75% of the time


» Job description


Employer:
Teva Biotech GmbH
Location:
89079 Ulm