QC Specialist/Expert (d/f/m) / Specialist/ekspert kontrole kakovosti (d/ž/m)

25! Is the number of team members in the Lek | Sandoz Analytical laboratory for small molecules, which you will join as a Quality Control Specialist. Together with the team, you will ensure that high-quality and appropriate finished products are released from production on time and thus indirectly contribut to the timely delivery of high quality and effective medicines to patients. If you're interested in advanced analytical techniques such as HPLC, TLC, CCIT and similar, this position is a great opportunity for you.

We are looking for a highly motivated and independent professional to take responsibility for performing and overseeing these methods in the analysis of our product for the treatment of osteoporosis – a metabolic bone disease. Your task will be to ensure quality throughout the entire process and to make sure the product meets all the 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 ToEnsuring that all activities are in line with current good practices (cGxP), and data integrity.

Exercising oversight of quality control activities. Reviewing and approving analytical tests (analytical release), batches of materials and products. Responsibility for the production and revision of general operating procedures and analytical documentation. Resolving analytical deviations, preparing reports, making suggestions for improvements. Participation in inspections (interpretation of primary data and methods of work). Stability testing (projects) protocol preparation, evaluation, report preparation. Reporting (stability plan preparation, trend analysis, evaluation). Performance of stability studies, protocols and comparative reports for supplier qualification. Interpretation and reporting of results and analysis of trends. Essential RequirementsUniversity 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 ReceiveEmployment 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: Slovenia (Ljubljana). For this position we do not offer relocation.

We offer a permanent contract with probation period of 6 months. You are kindly invited to submit your application in Slovene language, including your CV, by 3. 08. 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 & InclusionSandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

#Sandoz___________________________________________________________________________25! Je število članov ekipe Analitskega laboratorija za male molekule v lasti Lek Sandoz, kateri se boste pridružili kot Specialist kontrole kakovosti. Skupaj z ekipo boste z natančnim in zanesljivim izvajanjem analiz poskrbeli, da se kvaliteten in ustrezen končni izdelek sprosti iz proizvodnje in tako posredno vplivali k pravočasni oskrbi bolnikov z visoko kvalitetnimi in učinkovitimi zdravili. Če te zanimajo napredne analitske tehnike, kot so HPLC, TLC, CCIT in podobne, potem je ta razpis odlična priložnost zate.

Iščemo visoko motiviranega in samostojnega strokovnjaka, ki bi prevzel odgovornost za izvajanje in nadzor teh metod pri analizi našega izdelka za zdravljenje osteoporoze – presnovne bolezni kosti. Tvoja naloga bo zagotavljanje kakovosti skozi celoten proces ter skrb, da izdelek ustreza vsem predpisanim standardom in zahtevam. Če si natančen, sistematičen in te veseli delo v dinamičnem farmacevtskem okolju, te vabimo, da se prijaviš. Vaše Ključne OdgovornostiZagotavljanje, 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. 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). Preskušanje stabilnosti (projektov) in pripravljanje potrebnih analitičnih podatkov, protokolov in poročil. Izvajanje študij stabilnosti, protokolov in primerjalnih poročil za ustreznost oz. kvalifikacije dobaviteljev. Interpretiranje in poročanje o rezultatih ter analiziranje trendov.

Vaš Doprinos k Delovnem MestuVisokošolska 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 NudimoZaposlitev 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: Slovenija (Ljubljana). Relokacija za to pozicijo ni možna. Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas enega leta in s poskusno dobo 6 mesecev.

Prijave z življenjepisom lahko oddate najkasneje do 3. 08. 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 vključenostiSandoz 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