Senior AS&T specialist

Job Description
With its strategic investments in Slovenia, Sandoz is not just building factories – we are building the future
: for science, for people, and for global healthcare. To bring this vision to life, we are looking for dedicated, motivated, and passionate professionals who will contribute their knowledge and commitment to co-create a story of success.

As an
Senior
AS&T (Analytical Science and Technology) Specialist (d/f/m),
you will be responsible for planning and leading key activities, projects, and knowledge or technology transfers within product lifecycle management. Using your professional, technical, and regulatory expertise, you will solve complex tasks within cross-functional and international teams. Your role includes enhancing knowledge, implementing new technologies, optimizing processes, and shaping strategies in Quality Control and Analytical Science & Technology (AS&T). As a Subject Matter Expert (SME), you will contribute to professional excellence across the organization.

Your key responsibilities:

Your responsibilities include, but not limited to:

• Leading statistical analyses, method development, validation, comparisons, and transfers, including preparation of comprehensive reports.
• Providing active support for production-related projects, including product, process, and qualification validations.
• Introducing new techniques and technologies, and optimizing existing methods to enhance efficiency and performance.
• Responsibility for equipment qualification, calibration, maintenance, and handling malfunctions in compliance with GxP requirements.
• Operating in accordance with Slovenian and European legislation, FDA guidelines, international standards, and data integrity principles.
• Contributing to the development and oversight of the quality system, and actively participating in internal and external inspections.
• Providing expert support in resolving complex issues, managing exceptions and changes, and preparing risk assessments.
• Attending mandatory trainings, sharing knowledge, and taking responsibility for personal and professional growth.

What you will bring to the role:

• University-level education in pharmacy, biology, chemistry, microbiology, or another natural science discipline.
• Minimum of 5 years of work experience in quality, development, manufacturing, or another relevant field.
• Active proficiency in English.
• Familiarity with Microsoft Office tools.

You'll receive:

Employment at the most reputable employer in Slovenia offers 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 (WellBeat), Unlimited learning and development opportunities.

Possible job locations:
Slovenia
(Ljubljana, Brnik)

We offer
permanent contract with 6-month of probation period
. You are kindly invited to submit your application in English language, including CV, by

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. In delivering over 900 million treatments with Sandoz medicines to patients around the world, 20,000 people of more than 100 nationalities are involved. While we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged

The future is ours to shape

Commitment to Diversity & Inclusion:

Sandoz is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.

_______________________________________________________________________________________

Sandoz s svojimi strateškimi investicijami v Sloveniji ne gradi le tovarn, temveč prihodnost
– za znanost, za ljudi in za globalno zdravstvo. Da bi to vizijo uresničili, potrebujemo zavzete, motivirane in srčne strokovnjake, ki bodo s svojim znanjem in predanostjo soustvarjali zgodbo uspeha.

Kot
Višji
AS&T (Analitske znanosti in tehnologije) specialist (d/ž/m)
boste odgovorni za vodenje ključnih aktivnosti, projektov ter prenosov znanj in tehnologij v okviru življenjskega cikla izdelkov. Pri tem boste uporabljali strokovno, tehnično in regulativno znanje za reševanje kompleksnih nalog v medfunkcijskih in mednarodnih timih. Vaša vloga vključuje nadgradnjo znanja, uvajanje novih tehnologij, optimizacijo procesov ter oblikovanje strategij na področju kakovosti in analitike. Kot strokovnjak za svoje področje boste prispevali k razvoju odličnosti v organizaciji.

Vaše ključne odgovornosti:

• Vodenje statističnih analiz, razvoj, validacija, primerjava in prenos analitskih metod ter priprava obsežnih poročil.
• Aktivno sodelovanje pri projektih, povezanih s proizvodnjo, vključno z validacijo izdelkov, procesov in kvalifikacij.
• Implementacija novih tehnik in tehnologij ter optimizacija obstoječih metod za izboljšanje učinkovitosti.
• Odgovornost za kvalifikacijo, kalibracijo in vzdrževanje opreme ter obvladovanje okvar v skladu z GxP zahtevami.
• Delovanje v skladu s slovensko in evropsko zakonodajo, FDA smernicami, mednarodnimi standardi ter integriteto podatkov.
• Prispevanje k razvoju in nadzoru sistema kakovosti ter aktivno sodelovanje pri internih in zunanjih inšpekcijah.
• Nudenje strokovne podpore pri odpravljanju težav, upravljanju izjem in sprememb ter priprava ocen tveganja.
• Udeležba na obveznih izobraževanjih, prenos znanja ter odgovornost za osebni in strokovni razvoj.

Vaš doprinos k delovnem mestu:

• Visokošolska stopnja izobrazbe farmacevtske, biološke, kemijske, mikorbiološke ali druge naravoslovne smeri.
• Minimalno 5 let delovnih izkušenj na področju kakovosti, razvoja ali proizvodnje ali drugega ustreznega področja.
• Aktivno znanje angleškega jezik.
• Poznavanje orodja Microsoft Office.

Kaj nudimo:

Zaposlitev pri najuglednejšem delodajalcu v Sloveniji vam prinaša 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 (DobroBit) ter dogodke, neomejene priložnosti za učenje in razvoj.

Možne lokacije dela:
Slovenija
(Ljubljana, Brnik)

Z izbranim kandidatom bomo sklenili delovno razmerje za
nedoločen čas
in
s poskusno dobo 6 mesecev
.

Prijave z življenjepisom v angleškem in slovenskem jeziku lahko oddate najkasneje do

preko spletne povezave.

Zakaj Sandoz in Lek?

Generična in podobna biološka zdravila so hrbtenica svetovne industrije zdravil. Pri zagotavljanju več kot 900 milijonov terapij s Sandozevimi zdravili bolnikom po vsem svetu, sodeluje ljudi več kot 100 narodnosti. Na ta dosežek smo ponosni, a si želimo še več

Z naložbami v nove razvojne zmogljivosti, najsodobnejše proizvodne lokacije, nove pridobitve in partnerstva imamo priložnost oblikovati prihodnost Sandoza in Leka ter še večjemu številu bolnikov omogočiti trajnostni dostop do cenovno ugodnih in visokokakovostnih zdravil.

Naša zagon in podjetniški duh temeljita na odprti kulturi sodelovanja, katere srce so naši talentirani in ambiciozni sodelavci ter sodelavke. V okolju, kjer je raznolikost dobrodošla in kjer se spodbuja osebna rast, imajo v zameno za uporabo svojih znanj, možnost v celoti izkusiti delo v agilnem in povezovalnem okolju in z možnostjo fleksibilnega in hibridnega dela razvijati svojo kariero.

Prihodnost je v naših rokah

Predani smo raznolikosti in vključenosti:

Sandoz se zavzema za raznolikost, enake možnosti in vključenost. Prizadevamo si za oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.