Specialist kontrole kakovosti II – funkcionalno testiranje (m/ž/d) / QC Specialist II - Functional Testing (m/f/d)

Job Description Summary Prihodnost je v naših rokah. / The future is ours to shape. Job Description Na Brniku vzpostavljamo nov visokotehnološki center za proizvodnjo podobnih bioloških zdravil, v katerem bodo pomemben del tudi sodobni laboratoriji za kontrolo kakovosti. V novo QC ekipo vabimo Specialista kontrole kakovosti II na področju funkcionalnega testiranja , ki bo sodeloval pri vzpostavitvi laboratorija in procesov ter zagotavljanju kakovosti medicinskih pripomočkov (injekcij, avtoinjektorjev) za bioinjektabilne izdelke. V tej vlogi boste svoje analitsko in strokovno znanje povezovali z uvajanjem novih laboratorijskih procesov, funkcionalnim testiranjem medicinskih pripomočkov ter zagotavljanjem regulatorne skladnosti in kakovosti. Vaše ključne odgovornosti: Sodelovanje pri vzpostavitvi novega laboratorija za kontrolo kakovosti ter zagotavljanju njegove operativne pripravljenosti. Priprava analitske dokumentacije, vključno s specifikacijami, plani kontrole in plani vzorčenja za materiale in medicinske pripomočke, ki se uporabljajo pri proizvodnji bioinjektabilnih izdelkov. Sodelovanje pri uvajanju novih laboratorijskih informacijskih sistemov in z njimi povezanih laboratorijskih procesov. Sodelovanje pri prenosih analitskih metod ter pregled in odobravanje rezultatov rutinskega testiranja. Pregled in odobritev rezultatov funkcionalnega testiranja medicinskih pripomočkov. Raziskava laboratorijskih dogodkov, vključno z odstopi in rezultati izven specifikacijskih mej, ter sodelovanje pri upravljanju reklamacij in drugih aktivnostih, povezanih z GMP. Sodelovanje pri ocenjevanju vpliva sprememb na lokalne procese ter podpori pri uvajanju alternativnih virov dobave. Skrb za stalno pripravljenost področja na regulatorne inšpekcijske preglede. Vaš prispevek k delovnemu mestu: Visokošolsko izobrazbo farmacevtske, kemijske ali druge naravoslovne smeri. Zaželene delovne izkušnje s področja kakovosti, razvoja, proizvodnje ali drugega ustreznega področja. Prednost predstavljajo izkušnje s funkcionalnim testiranjem, medicinskimi pripomočki, analitskimi metodami ali delom v laboratorijskem okolju. Zaželeno poznavanje GMP okolja, laboratorijske dokumentacije in zahtev kakovosti. Aktivno znanje angleškega jezika. Poznavanje orodja Microsoft Office. Natančnost, odgovornost in sposobnost strokovnega ter samostojnega dela. Sposobnost sodelovanja z različnimi strokovnimi ekipami in motivacijo za soustvarjanje novega laboratorijskega okolja. Kaj nudimo: Lokacija dela: Brnik (do odprtja obrata bo delo potekalo v Ljubljani) 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 2026 je znašal 2.450,00 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 (zgornja zneskovna omejitev je 3.224,18 EUR letno). 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 28. novembra 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. --------------------------------------------------------------------------------------------------------------------------- At Brnik, we are establishing a new high-tech manufacturing center for biosimilars, which will include modern Quality Control laboratories as an integral part of the site. We are looking for a QC Specialist II in Functional Testing to join our new QC team and contribute to the establishment of the laboratory and its processes, as well as to ensuring the quality of medical devices used for biologic injectable products (injections, autoinjectors). In this role, you will combine your analytical expertise with the implementation of new laboratory processes, functional testing of medical devices, and activities supporting regulatory compliance and product and process quality. Your key responsibilities: Contribute to the establishment of the new Quality Control laboratory and ensure its operational readiness. Prepare analytical documentation, including specifications, control plans, and sampling plans for materials and medical devices used in the manufacturing of biologic injectable products. Support the implementation of new laboratory information systems and related laboratory processes. Participate in analytical method transfers and review and approve results from routine testing. Review and approve functional testing results for medical devices. Investigate laboratory events, including deviations and out-of-specification results, and support complaint management and other GMP-related activities. Participate in evaluating the impact of changes on local processes and support the introduction of alternative supply sources. Support continuous inspection readiness for regulatory inspections. What you will bring to the role: University degree in pharmacy, chemistry, or another natural science field. Previous working experience in quality, development, manufacturing, or another relevant field is preferred. Experience with functional testing, medical devices, analytical methods, or working in a laboratory environment is an advantage. Knowledge of a GMP-regulated environment, laboratory documentation, and quality requirements is preferred. Functional knowledge of English. Knowledge of Microsoft Office. Accuracy, accountability, and the ability to perform professional work independently. Ability to collaborate effectively across different expert teams and motivation to contribute to the establishment of a new laboratory environment. What we offer: Job location: Brnik (until the site opens, the position will be based in Ljubljana) Contract type: permanent contract with 6-month probation period Expected weekly working hours: 40 Pay range (annual gross salary): € 30.960 – 46.440 EUR* * 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 Ready for your next career move? You are kindly invited to submit your application in English and Slovene, including a CV, by November 28th 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