QA Compliance Specialist (d/f/m) / Specialist upravljanja kakovosti – skladnost (d/ž/m)

Job description

Job Description Summary The future is ours to shape! / Prihodnost je v naših rokah! Job Description We are looking for a motivated QA Compliance Specialist , who will be responsible for independently performing control and approval activities for analytical procedure validations, deviations, and support in the implementation of qualifications and validations. You will also be responsible for reviewing and approving documentation related to the quality control of our products. Your key responsibilities: Your responsibilities include, but are not limited to: Ensuring that all activities comply with current good practices (cGxP) and data integrity. Participating in the development, implementation, and control of the quality system and managing implementation in accordance with Slovenian and European legislation, FDA, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, the Pharmaceutical Inspection Convention, and Sandoz standards. Support in qualification and validation activities (planning, consulting, review). Review and approval of changes. Participation in investigations regarding deviations and complaints, management of corrective and preventive actions, and tracking of implementation. Preparation and support for audits and inspections. What you will bring to the role: Preferred university degree in pharmaceutical, chemical or other natural science field. Preferred work experience in laboratory, production, development or other professional experience in the field of quality. GMP knowledge. Active knowledge of English and Slovenian language. Good communication skills and the ability to take responsibility for your work. What we offer: Job location: Lendava, Slovenia Contract type: permanent contract with 6-month probation period Expected weekly working hours: 40 *Pay range: €30.960 – €46.440 gross per year * 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 2026 it was €2,450 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 Ready for your next career move? You are kindly invited to submit your application in English and Slovene, including a CV, by September 18th, 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 ___________________________________________________________________________________________________________________________________________________________ Iščemo motivirano osebo, ki bo kot Specialist upravljanja kakovosti – skladnost odgovorna za samostojno izvajanje aktivnosti nadzora in odobravanja validacij analitskih postopkov, odstopov ter podpore pri izvajanju kvalifikacij ter validacij. Prav tako boste odgovorni za pregled in odobritev dokumentacije povezane s kontrolo kakovostjo naših izdelkov. Vaše ključne odgovornosti: Zagotavljanje, da so vse dejavnosti v skladu s trenutnimi dobrimi praksami (cGxP), ter v skladu z integriteto podatkov. Sodelovanje pri razvoju, implementaciji in nadzoru sistema kakovosti in vodenje implementacije v skladu s slovensko in evropsko zakonodajo, FDA, mednarodnim svetom za usklajevanje tehničnih zahtev glede zdravil, Konvencijo o farmacevtski inšpekciji in Sandoz standardi. Podpora pri aktivnostih kvalifikacij in validacij (načrtovanje, svetovanje, pregled). Pregled in odobritev sprememb. Sodelovanje pri raziskavah glede odstopanj in reklamacij, upravljanje s korektivnimi in preventivnimi ukrepi ter sledenje implementacije. Priprava in podpora pri nadzorih in inšpekcijskih nadzorih. Vaš doprinos k delovnem mestu : Zaželena visokošolska stopnja izobrazbe farmacevtske, kemijske ali druge naravoslovne smeri. Zaželene delovne izkušnje s področja laboratorija, proizvodnje, razvoja ali druge strokovne izkušnje s področja kakovosti. Znanje in razumevanje GMP standardov. Aktivno znanje angleškega in slovenskega jezika. Dobre komunikacijske sposobnosti in sposobnost prevzemanja odgovornosti za svoje delo. Kaj nudimo: Lokacija dela: Lendava, Slovenija Vrsta pogodbe: pogodba za nedoločen čas s 6-mesečnim poskusnim obdobjem Predvideni tedenski delovni čas: 40 *Plačni razpon: 30.960 – 46.440 EUR bruto letno * 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 2026 je znašal 2.450 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. Ste pripravljeni na naslednji korak v karieri? Prijavo z življenjepisom v angleškem in slovenskem jeziku lahko oddate najpozneje do 18. septembra 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 Skills Desired