Lek, a Sandoz company
QC Specialist II (d/f/m) / Specialist/ekspert kontrole kakovosti (d/ž/m)
Lek, a Sandoz companySlovenia1 day ago
Full-timeRemote FriendlyQuality Assurance
Job Description

11! That’s the number of team members in the Lek, a Sanodz Company Analytical laboratory for small molecules, where you will join as a QC Specialist II. Together with the team, you will ensure that accurate and reliable analyses are performed so that high-quality and compliant final products leave production – directly contributing to the timely supply of safe and effective medicines to patients.

Your role will be to ensure quality throughout the entire process and make sure that the product meets all prescribed standards and requirements. If you are detail-oriented, systematic, and enjoy working in a dynamic pharmaceutical environment, we invite you to apply.

Your Responsibilities Include, But Not Limited To

  • Ensuring that all activities comply with current good practices (cGxP) and data integrity requirements, as well as exercising oversight of quality control activities.
  • Reviewing and approving analytical tests (analytical release), batches of materials and products for particle analysis of the final product / packaging / microscopy / complaints / stability / particle identification using IR and Raman spectroscopy.
  • Responsible for creating and revising standard operating procedures and analytical documentation.
  • Resolving analytical deviations, preparing reports, and providing suggestions for improvements.
  • Participating in inspections (explaining primary data and working methods).
  • Collaborating on projects from the perspective of particle analysis and preparing required analytical data, protocols, and reports.
  • Interpreting and reporting results, as well as analyzing trends.

Essential Requirements

  • University degree in pharmacy, chemistry or other equivalent natural science degree.
  • Preferred working experience in field of quality, development, manufacture, or another relevant field.
  • Functional knowledge of English and good knowledge of Slovene.
  • Knowledge of Microsoft Office.

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).

We offer a temporary contract with the possibility of extension to a permanent position, including a 6-month probation period

You are kindly invited to submit your application in Slovene language, including your CV, by 8.12. 2025.

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

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11! To je število članov ekipe Laboratorija za analizo delcev v Leku, čalnu skupine Sandoz, kamor se boste pridružili kot Specialist/ekpert kontrole kakovosti. Skupaj z ekipo boste z natančnim in zanesljivim izvajanjem analiz skrbeli, da iz proizvodnje pride kakovosten in ustrezen končni izdelek – s tem boste neposredno prispevali k pravočasni oskrbi bolnikov z varnimi in učinkovitimi zdravili.

Tvoja naloga bo zagotavljanje kakovosti skozi celoten proces ter skrb, da izdelek izpolnjuje vse predpisane standarde in zahteve. Če si natančen, sistematičen in te veseli delo v dinamičnem farmacevtskem okolju, te vabimo, da se prijaviš.

Vaše Ključne Odgovornosti

  • Zagotavljanje, da so vse dejavnosti v skladu s trenutnimi dobrimi praksami (cGxP), ter v skladu z integriteto podatkov. Izvajanje nadzora nad aktivnostmi v kontroli kakovosti.
  • Pregledovanje in odobravanje analitičnih testov (analitično sproščanje), serij materialov in izdelkov za analize delcev za končni izdelek / ovojnine/ mikroskopija / pritožbe / stabilnost / identifikacija delcev z IR in Ramansko spektroskopijo.
  • Odgovornost za izdelavo in revizijo splošnih operativnih postopkov in analizne dokumentacije.
  • Reševanje analitskih odstopov, pripravljanje poročil, podajanje predlogov za izboljšave.
  • Sodelovanje pri inšpekcijah (razlaga primarnih podatkov in načina dela).
  • Sodelovanje s stališča analize delcev pri projektih in pripravljanje potrebnih analitičnih podatkov, protokolov in poročil.
  • Interpretiranje in poročanje o rezultatih ter analiziranje trendov.

Vaš Doprinos k Delovnem Mestu

  • Visokošolska stopnja izobrazbe farmacevtske, kemijske ali druge ustrezne naravoslovne smeri.
  • Aktivno znanje angleškega in slovenskega jezika.
  • Poznavanje orodja Microsoft Office.
  • Zaželene delovne izkušnje s področja kakovosti, razvoja, proizvodnje ali drugih ustreznih smeri.

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).

Z izbranim kandidatom bomo sklenili delovno razmerje za določen čas enega leta z možnostjo podaljšanja v nedoločen čas in poskusno dobo 6 mesecev.

Prijave z življenjepisom lahko oddate najkasneje do 8.12.2025 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 20.000 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.

#Sandoz