QP (d/f/m) / Odgovorna oseba za sproščanje zdravil na trg (d/ž/m)

Job Description Summary

The future is ours to shape

Job Description

5500 is the current number of batches of medicines we supply annually to the Slovenian, European and global markets in the 14-member ESO (External Supplier Organisation) release team of Lek, a Sandoz company, which you will join as a QP.

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.

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 (Energized for Life), Unlimited learning and development opportunities. 

Possible job locations: Ljubljana

We offer permanent employment, with a 6-month probation period.

You are kindly invited to submit your application in the English or Slovene language, including CV by the 24th of November 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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5500 je število serij zdravil s katerimi na letni ravni oskrbujemo slovenski, evropski in svetovni trg v 14 članski ekipi za sproščanje ESO (External Supplier Organisation oz. Organizacija zunanjih dobaviteljev) v Lek, član skupine Sandoz, kateri se boste pridružili kot QP.

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? 

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 (Polni življenja) ter dogodke, neomejene priložnosti za učenje in razvoj. 

Možne lokacije dela: Ljubljana

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

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

Skills Desired

Continued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Gmp Procedures, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

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