Senior QC Specialist (d/f/m) / Višji specialist kontrole kakovosti (d/ž/m)

Job DescriptionWe are seeking a Senior QC Specialist, who will be responsible for independent and complex expertise in the Biosimilars analytical field in order to ensure regulatory compliance and quality of process and products in accordance with the law, internal regulations, good practices and business objectives. Responsibility for the development and transfer of expert skills from the quality control area. Subject matter expert for area of expertise.Your Key ResponsibilitiesYour responsibilities include, but are not limited to:You'll lead the entire process of setting up a new QC lab for testing biosimilars, from equipment acquisition and qualification to method transfer, team building, and establishing lab procedures.You'll ensure that all activities are in compliance with current good laboratory practice (cGxP), including data integrity. You'll manage analytical deviations, complaints, and implement corrective and preventive actions to ensure quality (CAPA).You'll support sample planning, execution, and analytical test approval for materials and final products.You'll actively collaborate with the QC network and contribute to developing global operating procedures (GOPs).You'll be responsible for analytical method validation, transfer, and issue management and participating in equipment selection/maintenance, onboarding associates, and providing support fort technological improvements.You'll develop and maintain key lab documents including SOPs, Certificates of Analysis, and analytical/registration documentation.You'll champion a safe and high-quality work environment by enforcing HSE rules, promoting safety culture, identifying risks, ensuring proper equipment use, participating in training, and handling waste responsibly.What You Will Bring To The RoleUniversity degree in pharmacy, chemistry or any other natural science degree.Minimum 5 years of working experience in the field of quality, development, manufacture in pharmaceutical or similar industries. Excellent understanding of biopharmaceutical processing and manufacturing. Thorough understanding of GMP and regulatory requirements.Advanced proficiency in English (written and spoken).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: LendavaWe 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 November 14th, 2025.Why Sandoz?Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and 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 #BioRampUp_________________________________________________________________________________________________________________________________________________________Kot Višji specialist kontrole kakovosti na področju podobnih bioloških zdravil boste zagotavljali, da naši izdelki in postopki izpolnjujejo predpise in standarde kakovosti. Svoje strokovno znanje in izkušnje boste uporabili za razvijanje spretnost tudi znotraj tima in delovali kot strokovnjak na svojem področju.Vaše Ključne OdgovornostiVodili boste celoten postopek postavitve novega QC laboratorija za preizkušanje podobnih bioloških zdravil, od nakupa opreme in kvalifikacije do prenosa metod, oblikovanja ekipe in vzpostavitve laboratorijskih postopkov. Zagotovili boste, da so vse dejavnosti v skladu s trenutno dobro laboratorijsko prakso (cGxP), vključno s celovitostjo podatkov. Upravljali boste z analitičnimi odstopanji, reklamacijami ter izvajali korektivne in preventivne ukrepe za zagotavljanje kakovosti (CAPA). Podpirali boste načrtovanje vzorcev, izvedbo in odobritev analitičnih testov za materiale in končne izdelke. Aktivno boste sodelovali z ostalimi ekipami v QC in prispevali k razvoju globalnih operativnih postopkov (GOPs). Odgovorni boste za potrjevanje analitičnih metod, prenosa in upravljanja morebitnih težav ter sodelovali pri izbiri/vzdrževanju opreme, izbiri novih sodelavcev in zagotavljali podpore za tehnološke izboljšave.Razvijali in vzdrževali boste ključne laboratorijske dokumente, vključno s SOP, potrdila o analizi in analitično/registracijsko dokumentacijo. Z uveljavljanjem pravil HSE, spodbujanjem varnostne kulture, prepoznavanjem tveganj, zagotavljanjem pravilne uporabe opreme, sodelovanjem pri usposabljanju in odgovornim ravnanjem z odpadki se boste zavzemali za varno in kakovostno delovno okolje.Vaš Doprinos k Delovnem MestuVisokošolska stopnja izobrazbe farmacevtske, kemijske ali druge naravoslovne smeri.Minimalno 5 let delovnih izkušenj na področju kakovosti, razvoja ali proizvodnje v farmacevtskih industriji ali na primerljivih delovnih mestih.Odlično razumevanje predelave biofarmacevtskih izdelkov in proizvodnje. Temeljito razumevanje GMP in regulativnih zahtev.Aktivno znanje angleščine (pisno in govorno).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: LendavaZ izbranim kandidatom bomo sklenili delovno razmerje nedoločen čas s poskusno dobo 6 mesecev.Prijave z življenjepisom v angleškem ali slovenskem jeziku lahko oddate najkasneje do 14. novembra 2025 preko spletne povezave.Zakaj Sandoz in Lek?Generična in podobna biološka zdravila so hrbtenica svetovne industrije zdravil. Sandoz se je kot vodilni v tem sektorju lani dotaknil življenj skoraj 500 milijonov bolnikov. 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 in 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 #BioRampUp