Job Description Summary

Job Description

40+ je število različnih molekul, za katere odgovarjamo s skrbnim nadzorom in zahtevnimi standardi kakovosti. Pridružite se nam in postanite del ekipe 50 strokovnjakov upravljanja kakovosti in sodelujte pri premikanju mej dostopnemu zdravljenju za bolnike.

Proizvodna enota Aseptični izdelki Ljubljana 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.

Za področje upravljanja kakovosti procesov, izdelkov in opreme v proizvodni enoti Aseptičnih izdelkov, iščemo Specialista upravljanja kakovosti.

Delovno mesto je odprto za namen:

• sodelovanja in upravljanja kakovosti pri projektu uvajanja nove opreme in tehnologije za nove farmacevtske oblike bioloških zdravil,
• sodelovanja in upravljanja kakovosti redne proizvodnje Aseptičnih izdelkov, ki vključuje različne proizvodne linije in različne farmacevtske oblike.

Z zaposlitvijo v našem podjetju vam bomo med drugim omogočili:

• učenje in spoznavanje zakonitosti aseptične proizvodnje ter postopkov za izdelavo sterilnih izdelkov,
• spoznavanje izbora in kvalifikacije opreme za zagotavljanje aseptičnih / sterilnih procesov,
• spoznavanje postopkov za vzpostavljanje razredov čistosti prostorov farmacevtske proizvodnje.

Vaše ključne odgovornosti:

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

• Sodelovali boste z ekspertnimi skupinami pri:
  - zagotavljanju standardov kakovosti novih tehnologij, procesov in izdelkov v fazi kliničnih testiranj  in za obstoječe procese redne proizvodnje,
  - zagotavljanju standardov kakovosti za strojno in sistemsko opremo,
  - izvedbi raziskav odstopov v proizvodnji, na strojni in sistemski opremi.  
• Sodelovali boste pri prenosu novih izdelkov v redno proizvodnjo.
• Pregledovali in potrjevali boste tehnično – tehnološko in kvalifikacijsko dokumentacijo. 
• Skrbeli boste za izobraževanje o dobrih farmacevtskih praksah.
• Uvajali in zagotavljali boste standarde za obvladovanje sprememb ter izdelavo letnih pregledov kakovosti izdelkov, procesov, opreme in sistemov.
• Razvijali boste interne sisteme kakovosti v skladu s farmacevtsko zakonodajo, dobrimi farmacevtskimi praksami in Lekovimi in Sandozovimi  smernicami kakovosti.

Vaš doprinos k delovnem mestu:

• Visokošolska stopnja izobrazbe ustrezne naravoslovne smeri (farmacija, kemija, kemijsko inženirstvo, kemijska tehnologija).
• Aktivno znanje angleškega jezika in slovenskega jezika.
• Delovne izkušnje s področja proizvodnje, razvoja in kakovosti.
• Želja po novih znanjih, osebnem razvoju, timskem delu in sodelovanju.

Kaj nudimo  

Zaposlitev pri najuglednejšem delodajalcu v Sloveniji vam prinaša konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in občasnim 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. 

Možna lokacija zaposlitve: Ljubljana, Slovenija.

Z izbranim kandidatom bomo najprej sklenili delovno razmerje za določen čas za obdobje 1 leta, s poskusno dobo 6 mesecev. Delovno razmerje za določen čas je predvideno predvsem za uvajanje nove opreme pri proizvodnji kliničnih serij novih farmacevtskih oblik. Po izteku 1 leta je pogodbo za določen čas možno podaljšati v delovno razmerje za nedoločen čas.

Prijave z življenjepisom v slovenskem jeziku lahko oddate najkasneje do 03.02. 2026 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

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40+ is the number of different molecules for which we are responsible through careful implementation and maintanance of quality standards. Join us and become part of a team of 50 quality assurance experts and work together to pioneer access for patients. 

Aseptics Ljubljana manufacturing unit provides advanced pharmaceutical products to patients around the world. We are increasingly focusing on biosimilars, which require exceptional quality of processes and procedures, and above all, high professionalism, dedication and commitment of all employees in the unit.

We are looking for a QA Operations Specialist to manage the quality of processes, products and equipment in the Aseptics Ljubljana manufacturing unit.

We’re opening this role to support:

• the rollout of new equipment for innovative pharmaceutical manufacturing;
• implementation of quality standards for the processes and equipment of regular pharmaceutical production for releasing the medicines to the markets.   

By joining our company, you will be able to:

• Become familiar with the principles of aseptic production and the procedures for manufacturing sterile products.
• Learn how to select and qualify equipment to ensure aseptic processes. 
• Get to know the procedures for establishing cleanliness zones in pharmaceutical production areas.

Your responsibilities include, but not limited to:

In our multidisciplinary working environment, you will have a dynamic and interesting career with the following roles and responsibilities:

• Collaborate with expert teams to ensure quality standards for new technologies, processes, and products during the clinical trial phase.
• Help maintain quality standards for equipment and system infrastructure.
• Participate in investigations of deviations related to manufacturing, equipment, and systems.
• Support the transfer of new products into commercial manufacturing.
• Review and approve technical, technological, and qualification documentation.
• Contribute to training and education in Good Pharmaceutical Practices (GxP).
• Help implement and maintain standards for change control and the preparation of annual product, process, equipment, and system quality reviews.
• Support the development of internal quality systems in line with pharmaceutical regulations, GxP, and Lek/Sandoz quality guidelines.

Essential Requirements:

• A university degree in a relevant science (pharmacy, chemistry, chemical engineering, chemical technology and other life sciences) or
• Active knowledge of English and Slovene.
• Work experience in production, development and quality.
• Desire for new skills, personal development, teamwork and cooperation.

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: Ljubljana, Slovenia.

We are offering a temporary contract position for the period of 1 year, with a probationary period of 6 months. The temporary contract is mainly intended for the introduction of new equipment and production of clinical batches of new pharmaceutical forms. After 1 year, the temporary contract can be extended into a permanent employment contract.

You are kindly invited to submit your application, including your CV, by 03.02.2026.  

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

Skills Desired