About this role
Job Description Summary
The future is ours to shape. / Prihodnost je v naših rokah.Job Description
Vsako leto več kot 10.000 serij zdravil zapusti naše proizvodne in dobaviteljske verige ter doseže slovenski, evropski in svetovni trg. Za to skrbi 20‑članska ekipa za sproščanje zdravil ESO (External Supplier Organisation).
Iščemo Odgovorno osebo za sproščanje zdravil na trg, ki bo prevzela pomembno vlogo izvajanja aktivnosti nadzora nad kakovostjo proizvedenih zdravil pred sproščanjem, z namenom nemotene oskrbe bolnikov ter zagotavljanje razvoja internega sistema kakovosti.
Vaše ključne odgovornosti:
- Pregled in ocena proizvodne in analitske dokumentacije.
- Ocena ustreznosti izdelanih serij in skladnosti z dovoljenjem za promet.
- Sproščanje zdravil na trg skladno z direktivami EU in FDA ter lokalno zakonodajo, določili pogodb s partnerji in internimi postopki.
- Razvoj internega sistema kakovosti z dobrimi farmacevtskimi praksami, zakonodajo ter Sandozovimi standardi.
- Skladnost procesov in postopkov z najvišjimi standardi kakovosti.
- Sodelovanje pri inšpekcijah.
- Ostale naloge določene z letnim pogovorom o ciljih in s kazalniki uspešnosti.
- Izvedba in upoštevanje vseh navodil in zahtev za zagotavljanje varnega dela, varovanja okolja in premoženja.
Vaš doprinos k delovnem mestu:
- Visokošolska izobrazba farmacevtske smeri.
- Izpolnjevanje pogojev, določenih v Zakonu o zdravilih (ZZdr-2), zlasti v 73. in 92. členu.
- Zaželene so izkušnje z delom na področju razvoja ali proizvodnje farmacevtskih izdelkov.
- Odlično znanje angleškega in slovenskega jezika.
- Dobro poznavanje orodij Microsoft Office.
- Visoka motiviranost za delo, samostojnost in samoiniciativnost, dobre komunikacijske sposobnosti ter sposobnost timskega dela.
- Zanesljivost, natančnost in sposobnost sprejemanja odločitev.
Kaj nudimo:
Lokacija dela: Ljubljana
Vrsta pogodbe: pogodba za določen čas enega leta s 6-mesečnim poskusnim obdobjem
Predvideni tedenski delovni čas: 40
*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
- Dodatek za izmensko delo (15 %); turnusno delo (20 %), nočno delo (70 %), delo ob nedeljah in praznikih (50 %), nadurno delo (30 %) – če to velja za zadevno delovno mesto
- 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 3. maj 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
___________________________________________________________
10,000 is the number of batches of medicines we supply annually to the Slovenian, European, and global markets. This is achieved through the work of our 20‑member ESO team (External Supplier Organisation), which ensures high standards of quality and compliance.
We are seeking a Qualified Person who will take on an important role of quality control activities for the manufactured medicinal products prior to release, with the purpose of ensuring smooth medicines supply to patients and development of an internal quality system.
Your key responsibilities:
Your responsibilities include, but are not limited to:
- Review and assessment of production and analytical documentation.
- Evaluation of the adequacy of the manufactured batches and compliance with the marketing authorization.
- Market release in accordance with EU, FDA and local legislation, requirements from the Quality assurance agreements with our customers and internal standards.
- Development of internal quality system, according to good pharmaceutical practices, legislation and Sandoz standards.
- Compliance of processes and procedures with the highest quality standards.
- Collaboration in inspections and audits.
- Other tasks determined by the annually set objectives and performance indicators.
- Implementation and observance of all instructions and requirements for ensuring safe work, protection of the environment and property.
What you will bring to the role:
- University degree in pharmacy.
- Compliance with the requirements set out in the Medicines Act (ZZdr-2), specifically Articles 73 and 92.
- Working experiences from development or manufacturing of medicinal products are desired
- Fully fluent in English and Slovene language.
- Knowledge of Microsoft Office tools.
- High motivation for work, independence and self-initiative, communication skills, ability to work in a team. Reliability, decision making.
What we offer:
Job location: Ljubljana
Contract type: temporary contract of 1 year with 6-month probation period
Expected weekly working hours: 40
*Pay range: €45,120 – €67,680 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
- Allowance for shift work (15%); rotational shifts (20%), night shift work (70%), Sunday/public holiday work (50%), overtime work (30%) – if applicable for position
- 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 May 3rd 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
Skills Desired
Change Control, Continued Learning, Dealing With Ambiguity, Guideline, Product Release, Qa (Quality Assurance), Quality Management, Regulation, Risk Management, Self-Awareness, Technological ExpertiseAbout Sandoz
Global leader in generic and biosimilar medicines, operating as an independent company spun off from Novartis. Based in Basel.
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