QA eCompliance Specialist supporting quality management and compliance for computerized systems in the pharmaceutical industry. Seeking proactive professionals with technical backgrounds in Ljubljana, Slovenia.
Responsibilities
Nudenje podpore pri dejavnostih za kvalifikacijo in validacijo računalniško podprtih sistemov (načrtovanje, svetovanje, pregled)
Zagotavljanje implementacije veljavnih Novartisovih in regulatornih zahtev za področje GxP računalniško podprtih sistemov
Pregled / odobritev nadziranja sprememb v sistemu
Zagotavljanje kakovosti procesa v skladu s predpisi
Zagotavljanje strokovnega znanja oz. usmeritev za zagotavljanje kakovosti in ustreznosti GxP relevantnih računalniško podprtih sistemov, ocenjevanje dobaviteljev, nadzor nad spremembami, obvladovanje odstopov in povezanih aktivnosti
Pregledovanje in potrjevanje ocen opreme/sistemov glede GxP relevantnosti
Implementiranje in razvijanje novih zmogljivosti v skladu s poslovnimi potrebami
Priprava in podpora pri revizijah in inšpekcijskih pregledih
Requirements
Visokošolska/univerzitetna izobrazba tehnične, računalniške ali druge naravoslovne smeri
Aktivno znanje angleškega jezika
Poznavanje orodja Microsoft Office
Minimalno 3 let delovnih izkušenj s področja avtomatizacije/CSV in /ali avtomatizacije procesov in sistemov ter standardov s področja računalniških sistemov v farmacevtski industriji ali drugi ustrezni industriji
Benefits
Konkurenčen plačni paket
Letni bonus
Fleksibilen način dela, z možnostjo prilagajanja urnika in delom od doma
Pokojninska shema
Shema nagrajevanja in priznanja dosežkov
Razširjeni program promocije zdravja na področju telesnega, duševnega in družbenega počutja (Polni življenja)
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