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. Submit your application with the CV in Slovenian and English language.

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 (Wellbeing), employment at Top SI Employer, 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.

_______

For Slovenia:

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. Prijavo oddajte z življenjepisom v slovenskem in angleškem jeziku.

Kaj nudimo:

Konkurenčen plačni paket, letni bonus, fleksibilen način dela, z možnostjo prilagajanja urnika in delom od doma, zaposlitev v podjetju s certifikatom TOP Employer, 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.

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

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
Operations

Business Unit
Innovative Medicines

Location
Slovenia

Site
Ljubljana

Company / Legal Entity
SI19 (FCRS = SI019) Novartis farmacevtska proizvodnja d.o.o.

Functional Area
Quality

Job Type
Full time

Employment Type
Temporary (Fixed Term)

Shift Work
No