Summary
About the Role
Vaše ključne odgovornosti:
• Razvoj internega sistema kakovosti na področju obvladovanja opreme, prostorov in sistemov v skladu s farmacevtsko zakonodajo, GMP zahtevami in Novartisovimi standardi kakovosti.
• Pregled in potrjevanje analitske dokumentacije vključno s kvalifikacijsko / validacijsko dokumentacijo.
• Sodelovanje pri inšpekcijskih nadzorih in pri izvedbi internih presoj
• Potrjevanje ustreznosti izvedenih raziskav o odstopih in akcij, po potrebi sodelovanje in usmerjanje poteka raziskav.
• Pregledovanje in odobritev sprememb.
• Zagotavljanje, da so vse dejavnosti v skladu s dobrimi praksami (cGxP), ter v skladu z integriteto podatkov.
Vaš doprinos k delovnem mestu:
• Visokošolska stopnja izobrazbe farmacevtske, kemijske, mikrobiološke ali druge ustrezne naravoslovne smeri.
• Aktivno znanje slovenskega in angleškega jezika.
• Poznavanje orodja Microsoft Office.
• Zaželene delovne izkušnje s področja kontrole kakovosti, analitskega testiranja, proizvodnje, razvoja ali druge strokovne izkušnje s področja kakovosti.
Z izbranim kandidatom bomo sklenili delovno razmerje za določen čas s poskusno dobo 6 mesecev.
Prijave z življenjepisom v slovenskem in angleškem jeziku lahko oddate preko spletne povezave.
Zakaj Novartis?
Naš namen je soustvarjati medicino za izboljšanje in podaljševanje življenja ljudi, naša vizija pa je postati najbolj cenjeno in zaupanja vredno farmacevtsko podjetje na svetu. Kako lahko to dosežemo? S pomočjo naših ljudi. Prav naši sodelavci nas vsak dan spodbujajo, da dosežemo svoje ambicije. Postanite del te misije in se nam pridružite! Več na spodnji povezavi: https://www.novartis.com/about/strategy/people-and-culture
Kaj nudimo:
Konkurenčen plačni paket, letni bonus, fleksibilen način dela, z možnostjo prilagajanja urnika in delom od doma, pokojninsko shemo, shemo nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in družbenega počutja (Polni življenja) ter dogodke, neomejene priložnosti za učenje in razvoj.
Predani smo raznolikosti in vključenosti
Novartis si prizadeva ustvariti izjemno, vključujoče delovno okolje in oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.
Pridružite se naši mreži Novartis:
V kolikor se ne prepoznate v zgornjem opisu delovnega mesta, vas vabimo, da se vpišete na spodnji povezavi v Novartisovo bazo talentov saj lahko tako vašo vlogo upoštevamo za podobne pozicije v prihodnosti: https://talentnetwork.novartis.com/network
Key Responsibilities:
• Ensure production and laboratory's GxP compliance and execution of activities in accordance with legislation, GMP requirements and Novartis quality standards.
• Review and approval of Quality Control (QC), and Analytical science and technology (AS&T) records (validations and transfer documentation).
• Support for inspections and audits. Participation in the execution of internal audits.
• Participation in deviation and OOX investigations, corrective and preventive actions management.
• Change control review and approval.
• Ensure all activities are in compliance with cGxP, incl. data integrity.
Essential Requirements:
• University degree in pharmacy, chemistry, microbiology or other equivalent natural science degree.
• Fluent in English and Slovene.
• Knowledge of Microsoft Office.
• Preferred experience in QC, analytical testing, production, development or other quality functions on expert position.
We offer a temporary employment for one year with 6 month of probation period.
You are kindly invited to submit your application in English and Slovenian language, including CV.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive:
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being, Unlimited learning and development opportunities.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
