Sammendrag
About the Role
Key Responsibilities:
• Approval and control of suppliers of input materials.
• Development of an internal quality system in line with pharmaceutical legislation, good pharmaceutical practice and Novartis standards. Managing complaints in the event of inadequate quality.
• Implement and maintain Quality Systems and Standard Operating Procedures defining all the processes for managing of External suppliers
• Review and validation of technical and engineering documentation.
• Conduct internal and external quality system audits (certify suppliers, contract suppliers and contract manufacturing suppliers).
• Preparing and conducting inspections. Approval of product, process and system validation and annual quality audits of products, processes and systems.
• Validating the adequacy of the surveys carried out on complaints and complaints, participating in and guiding the surveys where necessary.
Essential Requirements:
• Preferably university degree in pharmacy, biology, chemistry, microbiology other equivalent natural or engineering science degree.
• 1 year of experience in quality, development or production.
• Active knowledge of English.
• Knowledge of Microsoft Office.
• Highly motivated, independent and self-initiative.
We offer temporary employment, with 6 months of probation period.
You are kindly invited to submit your application in English 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 (Energized for Life), 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
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For Slovenia:
Lokacija: Slovenija, Ljubljana, #LI-Hybrid
Kot Specialist upravljanja kakovosti dobaviteljev (m/ž/d) boste odgovorni za sodelovanje in izvajanje aktivnosti vezanih na potrjevanje, oceno tveganja in vzdrževanje nadzora nad kakovostjo zunanjih dobaviteljev Novartisa. Skrb za to, da so vsi vidiki odnosa in upravljanja le-tega skladni z zahtevami GMP, regulatornimi zahtevami, Novartisovim Poslovnikom kakovosti in praksami farmacevtske industrije, v skladu z internimi predpisi, dobrimi praksami, zakonodajo in poslovnimi cilji. Podpora in zagovor inšpekcij ter presoj v okviru izvajanja aktivnosti.
Pridružite se nam in postanite specialist upravljanja kakovosti dobaviteljev v oddelku Upravljanja dobaviteljev, skladiščenja in distribucije.
Vaše ključne odgovornosti:
• Potrjevanje specifikacij materialov vstopnih surovin.
• Odobravanje in nadzor dobaviteljev vstopnih materialov.
• Razvoj internega sistema kakovosti v skladu s farmacevtsko zakonodajo, dobrimi farmacevtskimi praksami in Novartisovimi standardi. Vodenje reklamacij v primeru neustrezne kvalitete.
• Izdelava sistemskih in splošnih postopkov za vzpostavitev in zagotavljanje sistema kakovosti.
• Pregled in potrjevanje tehnično-tehnološke dokumentacije.
• Izvedba notranjih in zunanjih presoj sistema kakovosti (potrjuje dobavitelje, pogodbene dobavitelje in dobavitelje pogodbene proizvodnje).
• Priprava in vodenje inšpekcijskih nadzorov. Odobravanje validacije izdelkov, procesov, sistemov ter letnih pregledov kakovosti izdelkov, procesov in sistemov.
• Potrjevanje ustreznosti izvedenih raziskav o odstopih in reklamacijah, po potrebi sodeluje in usmerja potek raziskav.
Vaš doprinos k delovnem mestu:
• Univerzitetna stopnja izobrazbe farmacevtske, kemijske ali druge naravoslovne smeri.
• 1 leto delovnih izkušenj s področja kakovosti, razvoja ali proizvodnje.
• Aktivno znanje angleškega jezika.
• Poznavanje orodja Microsoft Office.
• Visoka motiviranost za delo, samostojnost in samoinciativnost.
Z izbranim kandidatom bomo sklenili delovno razmerje za določen čas s poskusno dobo 6 mesecev.
Prijave z življenjepisom v angleškem in slovenskem jeziku oddajte 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
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.
