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

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:

Zaposlitev pri najuglednejšem delodajalcu v Sloveniji vam prinaša konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in občasnim delom od doma, pokojninsko shemo, shemo nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in družbenega počutja (DobroBit) ter dogodke, neomejene priložnosti za učenje in razvoj.

Možne lokacije dela: Lendava (Slovenija)

Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev.

Prijave z življenjepisom v angleškem in slovenskem jeziku lahko oddate najkasneje do 15. marca 2026 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 vključenosti

Sandoz se zavzema za raznolikost, enake možnosti in vključenost. Prizadevamo si za oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.

#BioRampUp #Sandoz

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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.

You’ll receive:

Employment 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 (WellBeat), Unlimited learning and development opportunities. 

Possible job locations: Lendava (Slovenia)

We offer permanent employment, with a 6-month probation period. 

You are kindly invited to submit your application in the English language, including CV by March 15th, 2026.

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 & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. 

#Sandoz #BioRampUp

Skills Desired