QA Operations Expert (d/f/m) / Ekspert upravljanja kakovosti – operacije (d/ž/m)

Job Description Summary

The future is ours to shape. / Prihodnost je v naših rokah.

Job Description

Join one of the largest investments in pharmaceutical manufacturing in Slovenia and help shape the future of biosimilar medicines.

Through its strategic investments in Slovenia, Sandoz is not only building manufacturing facilities but also investing in the future of science, people, and global healthcare. To bring this vision to life, we are looking for committed, motivated, and passionate professionals who will contribute their expertise and dedication to our success story.

The Bioinjectables Manufacturing Unit in Brnik will provide advanced pharmaceutical products to patients around the world. Our focus is increasingly on biosimilar medicines, which require exceptional process quality and operational excellence, as well as a high level of expertise, commitment, and engagement from all employees within the unit.

As a QA Operations Expert (d/f/m) on the project for the new manufacturing and testing site for finished bioinjectable products in Brnik, you will be responsible for ensuring quality management of combination product assembly processes (autoinjectors and needle safety devices), packaging operations, and compliance of processes and products with GMP and regulatory requirements.

By joining our company, you will have the opportunity to:

• Work in the manufacturing and quality control of combination products used for the administration of bioinjectable medicines.
• Take responsibility for establishing autoinjector and needle safety device assembly processes.
• Implement regulatory requirements and guidelines for combination products in the EU and the US.
• Participate in the introduction of new products and technologies into manufacturing.

Key Responsibilities

In our multidisciplinary working environment, you will have a dynamic and engaging role with the following responsibilities:

• Develop and maintain quality systems in accordance with pharmaceutical regulations, Good Manufacturing Practice (GMP) requirements, and Sandoz internal guidelines.
• Provide quality support for combination product assembly processes and finished product packaging operations.
• Review and approve manufacturing documentation, validation documentation, and batch manufacturing records.
• Participate in the management of deviations, complaints, changes, risk assessments, and the implementation of corrective and preventive actions (CAPA).
• Support equipment qualification activities, process validations, and the introduction of new products and technologies.
• Perform batch documentation review activities.
• Participate in internal and external audits, as well as regulatory inspections.
• Collaborate closely with Manufacturing, Engineering, Validation, Quality Control, Regulatory Affairs, and other technical functions to ensure compliance and continuous process improvement.
• Support the transfer of new products into commercial manufacturing.

What You'll Bring to the Role

• University degree in Pharmacy, Chemistry, Biotechnology, Mechanical Engineering, Medical Technology, or another relevant scientific or technical discipline.
• Proficiency in Slovenian and English.
• At least 3 years of experience in manufacturing, development, or quality within the pharmaceutical, medical device, or another regulated industry.
• Experience in the manufacturing of combination products, medical devices, autoinjectors, or needle safety systems is considered an advantage.
• Knowledge of European and US regulations for medical devices and combination products (EU MDR, FDA Combination Products) is considered an advantage.
• A strong desire for continuous learning, professional development, teamwork, and collaboration.

What we offer:

• Job location: Ljubljana and Brnik
• Contract type: temporary contract with 6-month probation period
• Expected weekly working hours: 40
• *Pay range: 45.120 – 67.680 EUR gross

*Salary at Sandoz is based on job level, qualifications, specific skills, and work experience. Fully proficient candidates are usually placed around the market median, less experienced candidates lower in the range, and those with strong or niche expertise higher. When determining placement within the range, we also consider internal pay equity and external market data.

Our compensation package additionally includes:

• Annual bonus (STI): percentage of annual salary
• Vacation allowance: in 2025 it was €2,430.99 net
• Christmas bonus: in 2025 it was €2,100 gross
• OurShare: every year, an employee of Lek d.d. will be entitled to receive shares of Sandoz AG
• Voluntary Additional Pension Scheme: The company fully covers the contribution for your supplementary pension plan, amounting to 5.844% of your gross salary
• Collective life and accident insurance (24/7 coverage)
• A hybrid work environment offering flexibility and remote work possibilities – if applicable for position

Ready for your next career move?
You are kindly invited to submit your application in English and Slovene, including a CV, by Friday, August 21st, 2026.

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have the ambition to do more so that everyone can benefit from the basic human right of good health.

With investments in new development capabilities, production sites, new acquisitions and partnerships, we have the opportunity to shape a sustainable future for Sandoz and to help even more people gain access to low-cost, high-quality medicines.

Our momentum 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 where diversity of thought is welcomed and where personal growth is supported! 

Join us in helping to make healthcare fairer and faster.

The future is ours to shape.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and to forming diverse teams that are representative of the patients and communities we serve. 

  

#Sandoz

~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~

Pridružite se eni največjih naložb v farmacevtsko proizvodnjo v Sloveniji in soustvarjajte prihodnost podobnih bioloških zdravil.

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.

Proizvodna enota bioinjektabilnih izdelkov na Brniku bo zagotavlja napredne farmacevtske izdelke bolnikom po vsem svetu. Pri tem se vse bolj usmerjamo na biološko podobna zdravila, ki zahtevajo izjemno kakovost procesov in postopkov, predvsem pa visoko strokovnost, predanost in zavzetost vseh zaposlenih na enoti.

Kot Eskpert upravljanja kakovosti – operacije (d/ž/m) na projektu za novo lokacijo za proizvodnjo in testiranje končnih bioinjektabilnih izdelkov na Brniku boste odgovorni za področje upravljanja kakovosti procesov sestavljanja kombinacijskih izdelkov (avtoinjektorjev in sistemov za zaščito igle), procesov pakiranja ter zagotavljanja skladnosti procesov in izdelkov z GMP ter regulatornimi zahtevami.

Z zaposlitvijo v našem podjetju vam bomo med drugim omogočili:

• Delo v proizvodnji in kontroli kakovosti kombinacijskih izdelkov za aplikacijo bioinjektabilnih zdravil.
• Odgovornost za vzpostavitev procesov sestavljanja avtoinjektorjev in sistemov za zaščito igle.
• Implementacijo zahtev regulatornih smernic za kombinacijske izdelke v EU in ZDA.
• Sodelovanje pri uvajanju novih izdelkov in tehnologij v proizvodnjo.

Vaše ključne odgovornosti:

V našem multidisciplinarnem delovnem okolju  boste imeli dinamično in zanimivo delo z naslednjimi delovnimi nalogami in odgovornostmi:

• Razvijali boste in vzdrževali sisteme kakovosti v skladu s farmacevtsko zakonodajo, dobrimi proizvodnimi praksami (GMP) ter internimi smernicami Sandoza.
• Zagotavljali boste kakovostno podporo proizvodnim procesom sestavljanja kombinacijskih izdelkov ter pakiranja končnih izdelkov.
• Pregledovali in odobravali boste proizvodno dokumentacijo, validacijsko dokumentacijo in zapise o izdelavi serij.
• Sodelovali boste pri obravnavi odstopanj, reklamacij, sprememb, ocenjevanju tveganj in izvajanju korektivnih ter preventivnih ukrepov (CAPA).
• Podpirali boste kvalifikacije opreme, validacije procesov ter uvajanje novih proizvodov in tehnologij.
• Izvajali boste pregled proizvodne dokumentacije serij.
• Sodelovali boste pri internih in zunanjih presojah ter regulatornih inšpekcijah.
• Tesno boste sodelovali s proizvodnjo, inženiringom, validacijami, kontrolo kakovosti, regulativo in drugimi strokovnimi skupinami pri zagotavljanju skladnosti in stalnih izboljšav procesov.
• Sodelovali boste pri prenosu novih izdelkov v redno proizvodnjo.

Vaš doprinos k delovnem mestu:

• Visokošolska stopnja izobrazbe farmacevtske, kemijske, biotehnološke, strojne, medicinsko-tehnične ali druge ustrezne naravoslovne oziroma tehnične smeri.
• Aktivno znanje slovenskega in angleškega jezika.
• Vsaj 3 leta delovnih izkušenj s področja proizvodnje, razvoja ali kakovosti v farmacevtski, medicinski ali sorodni regulirani industriji.
• Prednost predstavljajo izkušnje s področja proizvodnje kombinacijskih izdelkov, medicinskih pripomočkov, avtoinjektorjev ali sistemov za zaščito igle.
• Prednost predstavlja poznavanje evropske in ameriške regulative za medicinske pripomočke in kombinacijske izdelke (EU MDR, FDA Combination Products).
• Želja po novih znanjih, osebnem razvoju, timskem delu in sodelovanju.

Kaj nudimo:

• Lokacija dela: Ljubljana in Brnik
• Vrsta pogodbe: pogodba za določen čas za obdobje enega leta in s 6-mesečnim poskusnim obdobjem
• Predvideni tedenski delovni čas: 40 ur/teden
• *Plačni razpon: 45.120 – 67.680 EUR bruto

*Plača v Sandozu temelji na nivoju delovnega mesta, kvalifikacijah, specifičnih veščinah in znanjih ter delovnih izkušnjah. Visoko usposobljeni kandidati so običajno umeščeni okoli mediane plačnega razpona, manj izkušeni na spodnji del razpona, kandidati z izrazito močnimi ali nišnimi kompetencami pa višje. Pri umeščanju v plačni razpon upoštevamo tudi notranjo uravnoteženost plač in zunanje tržne podatke.

Naš paket ugodnosti dodatno vključuje:

• Letni bonus (STI): odstotek letne plače.
• Regres za letni dopust: leta 2025 je znašal 2.430,99 EUR (neto).
• Božičnica: leta 2025 je znašala 2.100 EUR (bruto).
• OurShare: Vsako leto bo zaposleni v družbi Lek d.d. upravičen do prejema delnic družbe Sandoz AG.
• Prostovoljno dodatno pokojninsko zavarovanje: družba Lek d.d. v celoti krije mesečni prispevek za dodatno pokojninsko zavarovanje v višini 5,844 % vaše mesečne bruto plače.
• Kolektivno življenjsko in nezgodno zavarovanje (kritje velja 24/7).
• Hibridno delovno okolje, ki omogoča fleksibilnost in možnost dela na daljavo. – če to velja za zadevno delovno mesto.

Ste pripravljeni na naslednji korak v karieri?
Prijavo z življenjepisom v angleškem in slovenskem jeziku lahko oddate najpozneje do petka, 21. avgusta 2026

Zakaj Sandoz?

Sandoz je vodilni svetovni proizvajalec generičnih in podobnih bioloških zdravil – segmenta zdravstvene industrije, ki zagotavlja 80 % vseh zdravil na svetu po 30-odstotni ceni ter s tem vpliva na življenja več kot milijarde ljudi v več kot 100 državah. Čeprav smo ponosni na svoje dosežke, si prizadevamo narediti še več, da bi vsakdo imel dostop do temeljne človekove pravice – pravice do dobrega zdravja.

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

Naš zagon temelji na odprti kulturi sodelovanja, katere srce so naši talentirani in ambiciozni sodelavci in sodelavke. V okolju, kjer so raznoliki načini razmišljanja dobrodošli in kjer se podpira osebna rast, imajo v zameno za uporabo svojih znanj možnost v celoti izkusiti delo v agilnem in povezovalnem okolju ter razvijati svojo uspešno kariero. 

Pridružite se nam in nam pomagajte povečati pravičnost in hitrost zdravstvenega varstva.

Prihodnost je v naših rokah.

Predani smo raznolikosti in vključenosti:

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

  

#Sandoz

Skills Desired