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International Open Positions

With 530 years of heritage, more than 3.000 employees, a leading Research and Development Center and two major production sites in Prague and Bucharest, Zentiva strives to be the champion of Generics to support the daily healthcare needs of people living in Europe.The growth of our organization brings new opportunities for our people to fulfil their potential. It also positions us well to attract the best talent and retain our team to secure our success for future generations. Join us!

Drug Master File Department Support - DPP / DPČ

Your responsibilities:

Zentiva products DMF support for all Zentiva sites, External documentation evaluation related to API (ASMF, CEP, and TP), API documentation maintenance within an assigned portfolio according to the valid legislation and information received from external partners, change control management related to any API changes within assigned portfolio API in all Zentiva sites.

Documentation related to active substance evaluation from external suppliers requested by Procurement or Regulatory Affairs
Comments communication to Procurement or directly with external suppliers / contractors

  • Change control management related to any API changes within assigned portfolio API in all Zentiva sites
  • Documentation preparation in eDMS including requested documentation (LoA, LoE, declarations...) for registration purposes
  • Valid documentation maintenance according to the valid legislation and notification from contract partners

We require:

University degree in Natura/Chemical Science/Pharmacy

  • Experiences in pharmaceutical industry is an advantage
  • An ability to lead projects
  • Excellent communication skills
  • Knowledge of relevant legislation in EU countries, CR, SR is an advantage

We offer:

  • An opportunity to work for a successful international company in friendly environment
  • An opportunity to broaden your organizational skills

Contact

Zentiva
Klára Pavlíková