Ekspert upravljanja kakovosti – operacije (d/ž/m) / QA Operations Expert (d/f/m)

Job description

Job Description Summary Prihodnost je v naših rokah! / The future is ours to shape. Job Description Iščemo predanega Eksperta upravljanja kakovosti – operacije , ki bo vodil in izvajal ključne aktivnosti kakovosti v naši biološki proizvodnji v GMP‑reguliranem okolju. Vloga zahteva odlično poznavanje pravil in zakonodaje, regulatornih zahtev, industrijskih standardov ter sistemov kakovosti. Izbrani kandidat bo odgovoren za natančen pregled in odobritev GxP dokumentacije na področju Proizvodnje, Inženiringa, Skladišča in Laboratorija. Poleg tega bo vodil celovito upravljanje notranjih in zunanjih projektov, osredotočenih na kakovost, zagotavljal skladnost ter spodbujal kulturo stalnih izboljšav. Vaše ključne odgovornosti: V našem multidisciplinarnem delovnem okolju boste imeli dinamično in zanimivo delo z naslednjimi delovnimi nalogami in odgovornostmi: Ocenjevanje ustreznosti vstopnih materialov in medfaznih proizvodov ter spoščanje serij za uporabo v proizvodnji v skladu z notranjimi predpisi in veljavno zakonodajo. Sodelovanje pri pregledu in odobritvi kvalifikacije ter validacije sistemov in opreme v skladu z notranjimi standardi Sandoza ter relevantnimi regulativnimi smernicami (EU Priloga 11 in 15, 21 CFR Part 11). Sodelovanje pri pregledu in odobritvi elektronskih proizvodnih zapisov ter proizvodnih in inženirskih odstopanj, upravljanja CAPA in postopkov sprememb. Opravljanje vloge QA odgovorne osebe za zagotavljanje skladnosti in vzdrževanje nadzora skozi celoten življenjski cikel sistemov, opreme in procesov. Posodabljanje in pregledovanje dokumenta strategije obvladovanja kontaminacije ter zagotavljanje njegove skladnosti z notranjimi standardi Sandoza in regulativnimi zahtevami (EU Priloga 1 in 2). Pregled in odobritev standardnih operativnih postopkov za proizvodnjo in inženiring. Odgovornost za posodobitev in pregled letnega kakovostnega pregleda proizvodnje (APQR). Podpora dejavnostim, povezanim z izdajo bioloških proizvodov na trg. Prispevanje k načrtovanju dela v oddelku, usklajevanje prioritet z drugimi oddelki ter sodelovanje pri preiskavah odstopanj in upravljanju sprememb. Izvajanje izboljšav in optimizacij procesov z namenom poenostavljanja kakovostnih procesov. Podpora razvoju notranjega sistema kakovosti v skladu z dobro farmacevtsko prakso, zakonodajo in standardi Sandoza ter zagotavljanje, da procesi in postopki dosegajo najvišje kakovostne standarde. Opravljanje drugih nalog, določenih z letno opredeljenimi cilji in kazalniki uspešnosti. Zagotavljanje operativne podpore QA pri inšpekcijah in avditih ter prispevanje k razvoju in vzdrževanju notranjega sistema kakovosti v skladu s farmacevtsko zakonodajo, GMP in standardi kakovosti Sandoza. Vaš doprinos k delovnem mestu: Univerzitetna izobrazba iz biotehnologije, farmacije, kemije ali druge ustrezne naravoslovne smeri. Aktivno znanje angleškega in slovenskega jezika. Zaželeno najmanj 10 let delovnih izkušenj na področju zagotavljanja kakovosti, proizvodnje ali kontrole kakovosti. Želja po pridobivanju novih znanj, osebnem razvoju, timskem delu in sodelovanju. Kaj nudimo: Lokacija dela: Lendava (Slovenija) Vrsta pogodbe: pogodba za nedoločen čas s 6-mesečnim poskusnim obdobjem Predvideni tedenski delovni čas: 40 *Plačni razpon: 45.120 - 67.680 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 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 26 . junija 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 _______________________________________________________________________________ We are looking for a highly committed QA Operations Expert to lead and execute essential quality activities within our Biologics facility operating in a GMP-regulated environment. This role requires strong expertise in regulatory expectations, industry standards, quality systems, and applicable rules and guidelines. The successful candidate will take ownership of rigorous review and approval processes for GxP documentation across Production, Engineering, Warehouse, and Laboratory areas. In addition, they will drive end‑to‑end management of quality‑focused internal and external projects, ensuring full compliance while fostering a culture of continuous improvement. Your responsibilities include, but not limited to: In our multidisciplinary working environment, you will have a dynamic and interesting career with the following job roles and responsibilities: Assess the adequacy of incoming materials and intermediate products and release them for use in production in accordance with internal regulations and applicable legislation. Participate in the review and approval of system and equipment qualification and validation activities, in line with Sandoz internal standards and relevant regulatory guidelines (EU Annex 11 & 15, 21 CFR Part 11). Participate in the review and approval of electronic batch records, as well as production and engineering deviations, CAPA management, and change control processes. Serve as QA responsible for ensuring compliance and maintaining the state of control throughout the lifecycle management of systems, equipment, and processes. Update and review the Contamination Control Strategy document and ensure its governance in accordance with Sandoz internal standards and regulatory requirements (EU Annex 1 and 2). Review and approve standard operating procedures for production and engineering. Responsible for the update and review of APQR. Support activities related to the market release of biologics products. Contribute to departmental work planning, coordinate priorities with other departments, and participate in deviation investigations and change management. Implement process improvements and optimizations aimed at simplifying quality processes. Support the development of the internal quality system in alignment with good pharmaceutical practices, legislation, and Sandoz standards, ensuring that processes and procedures meet the highest quality requirements. Perform other tasks as defined by annually established objectives and performance indicators. Provide QA operational support during inspections and audits and contribute to the development and maintenance of the internal quality system in accordance with pharmaceutical legislation, GMP, and Sandoz Quality Standards. Essential Requirements: A university degree in Biotechnology, pharmacy, chemistry or other equivalent natural science degree. Active knowledge of English and Slovene. Preferred min.10 years of work experience in Quality assurance, production and Quality control. The desire for new skills, personal development, teamwork and cooperation. What we offer: Job location: Lendava (Slovenia) Contract type: permanent contract with 6-month probation period Expected weekly working hours: 40 *Pay range: €45.120 - €67.680 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 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 Allowance for shift work (15%); rotational shifts (20%), night shift work (70%), Sunday/public holiday work (50%), overtime work (30%) – if applicable for position 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 June 26th, 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