Specialist upravljanja kakovosti – operacije,… at Sandoz · Ljubljana

Specialist upravljanja kakovosti – operacije, odgovoren za sproščanje vstopnih materialov (d/ž/m) / QA Operations Specialist, responsible for incoming materials release (m/f/d) Location: Ljubljana (Sandoz) Job Description Summary Prihodnost je tu, oblikujmo jo skupaj. / The future is ours to shape. Job Description Opis delovnega mesta V ekipi Upravljanja kakovosti – operacije smo ključna točka za sproščanje vstopnih materialov v proizvodnjo – od pregleda dokumentacije do končne odločitve o ustreznosti materialov za uporabo v proizvodnji. Iščemo osebo, ki ji ustreza delo z dokumentacijo, sodelovanje z več deležniki in odgovornost za kakovost v kompleksnem GMP okolju. Vaše ključne odgovornosti: Pregled in ocena nabavne in analitske dokumentacije vstopnih materialov (učinkovin in pomožnih snovi). Ocena ustreznosti serij vstopnih materialov in sproščanje serij za namen uporabe v proizvodnji, skladno z internimi predpisi, regulatornimi statusi ter zakonodajo. Načrtovanje dela in usklajevanje prioritet z drugimi oddelki. Sodelovanje pri obravnavi odstopov, sprememb in spremljanju kazalcev uspešnosti. Priprava periodičnih pregledov kakovosti vstopnih materialov. Sodelovanje pri nadgradnji sistema kakovosti ter zagotavljanje skladnosti s GMP, zakonodajo in Sandoz standardi. Sodelovanje pri inšpekcijah in presojah. Vaš prispevek k delovnemu mestu: Visokošolska stopnja izobrazbe farmacevtske, kemijske ali druge ustrezne naravoslovne smeri. Zaželeni vsaj 2 leti delovnih izkušenj s področja analitike, proizvodnje, razvoja ali druge strokovne izkušnje s področja kakovosti. Aktivno znanje angleškega in slovenskega jezika. Zanesljivost, natančnost, organiziranost, timska naravnanost in sposobnost sprejemanja odločitev. Kaj nudimo: Lokacija dela: Ljubljana Vrsta pogodbe: pogodba za nedoločen čas s 6-mesečnim poskusnim obdobjem Predvideni tedenski delovni čas: 40 ur Plačni razpon (letna bruto plača): 30.960 – 46.440 EUR* 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 22.05.2026. 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 _____________________________________________________________________ QA Operations Specialist, responsible for incoming materials release (m/f/d) Job Description In our QA Operations team, we are a key link in the manufacturing process, responsible for releasing incoming materials – from reviewing documentation to making critical decisions on their suitability for production. We are looking for someone who enjoys working with documentation, collaborates effectively across teams, and is motivated to take responsibility for quality in a dynamic GMP environment. Your key responsibilities: Review and assessment of procurement and analytical documentation of incoming materials (APIs and excipients). Assessment of adequacy of incoming materials batches and release of batches for the purpose of use in production, in accordance with internal regulations, regulatory statuses and legislation. Work planning and alignment of priorities with other departments. Participation in the handling of deviations, change controls, and monitoring of performance indicators. Preparation of periodic quality reviews of incoming materials. Contribution to the continuous improvement of the quality system and ensuring compliance with GMP, regulatory requirements, and Sandoz standards. Participation in inspections and audits. What you will bring to the role: University degree in Pharmacy, Chemistry, or another relevant natural sciences field. Experience in analytics, manufacturing, development, or other relevant quality-related roles is considered an advantage. Proficiency in English and Slovenian. Strong reliability, attention to detail, organizational skills, teamwork mindset, and decision-making ability. What we offer: Job location: Ljubljana Contract type: permanent contract with 6-month probation period Expected weekly working hours: 40 Pay range (annual gross salary): € 30.960 - € 46.440* 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 May 22nd, 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 Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence