Global Quality Data Compliance Expert Associate will be responsible for the maintenance of Shelf-life data and registration information within quality data base systems. Contains crosscheck valid marketing authorizations and the providence of the relevant information to the packagers.
- Creation/review and approval of the Labeling Instructions, which are documents containing the registered shelf life and if applicable all FMD-relevant data. Information for calculation of the variable data, the batch identifier, and the expiry date and their format which will be printed on the primary and secondary packaging materials, to ensure compliance with the marketing authorization documents.
- Processing of SAP workflows concerning shelf life, temperature conditions, registrations and formula codes.
- Shared documentation follow up.
- Support of technical discussion of quality deficiencies in medicinal products with the regulatory and site stakeholders
- Worldwide communication with the group's own production facilities and third parties
- Reporting KPIs
- Execution and providing training according to area of responsibility.
- Supports to global quality project(s) according to agreed project plans.
- University degree in pharmacy, biology, chemistry, or comparable course of study (f/m/d)
- English language – B2 mandatory, C1 level advantage
- Advanced level of knowledge of MS Office package
- Good communication and negotiation skills
- Fast learner and easily adaptable to changes.
- Ability to work in a fast-paced, dynamic environment.
- Ability to understand and discuss complex topics.
- Team-oriented, precise, analytical, responsible.
- Ability to work in cross functional teams
- Availability to travel for team meetings
- Private healthcare insurance (with the option of privileged usage for family members)
- Ongoing professional development through specialized education and training
- A platform for learning 14 foreign languages, using various learning styles, including conversation courses
- Personalized mental health and well-being support for employees and their families through the Kyan Health app
Hemofarm AD
Već 65 godina želimo vam - svako dobro - jer znamo da je dobro zdravlje naše najveće bogatstvo. Naša istorija počinje davne 1960. u severnoistočnom delu Srbije. Šest decenija bilo je dovoljno da se od malog vršačkog pogona razvijemo do kompanije koja posluje na tri kontinenta. Danas smo deo globalne STADA porodice kojoj smo se priključili 2006. godine. Zajedno sa matičnom kućom, celokupan pristup poslovanju kao i svoj korporativni identitet gradimo na četiri ključne vrednosti: Agility, Entrepreneurship,…
Iskustva zaposlenih
"Ponosan sam što radim u proizvodnji lekova, jer osećam da doprinosim nečemu važnom i korisnom za celo društvo.
Svaki dan me motiviše saznanje da moj rad ima direktan uticaj na zdravlje i dobrobit ... " Pročitajte celo iskustvo
Beneficije
- Fleksibilno radno vreme
- Hrana i piće
- Dobrovoljno zdravstveno osiguranje
- Edukacija, profesionalni razvoj
- Nagrade, bonusi, pokloni