QA Compliance Expert

Job Description
With its strategic investments in Slovenia, Sandoz is not just building factories, but shaping the future – for science, for people, and for global healthcare. To realize this vision, we need dedicated, motivated, and passionate professionals who will co-create a success story with their knowledge and commitment.

As a
QA Compliance Expert (d/f/m) on the project for the new location for manufacturing and quality control
of aseptic bioinjectable products at Brnik
, you will be responsible for executing complex tasks in the field of quality and ensuring compliance with regulatory requirements and internal Sandoz|Lek standards. Your work will be aligned with your area of expertise, applicable legislation, good practices, and business objectives. You will take ownership of risk management, inspection readiness, and quality management activities. Additionally, you will lead and coordinate more complex internal and external projects.

Your Key Responsibilities

• Ensuring that all activities are compliant with current good practices (cGxP), legislation, internal standards, and data integrity.
• Preparing and approval of operational procedures for GMP activities in production and quality control.
• Support of qualifications of chambers and warehouses.
• Supporting qualification and validation activities (of manufacturing and analytical procedures, including equipment cleaning validation), including planning, consulting, and documentation review.
• Managing quality systems, including documentation, internal audits, and compliance monitoring.
• Preparing, coordinating, and monitoring corrective and preventive actions (CAPA), as well as handling deviations and complaints.
• Preparing and supporting inspections and communicating with health authorities and global audit teams.
• Leading and participating in complex local and global projects, strategic initiatives, and promoting continuous improvement and operational excellence.

What You Will Bring To The Role

• University degree in pharmacy, biology, chemistry, microbiology, or another relevant natural science field.
• Minimum of 3 years of professional experience in manufacturing, development, or other quality-related areas.
• Proficiency in English and Slovenian.
• Good knowledge of Microsoft Office tools.

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:
Slovenia
(Ljubljana and Brnik)

We offer
permanent contract with 6-month of probation period
. You are kindly invited to submit your application in English language, including CV, by

Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. In delivering over 900 million treatments with Sandoz medicines to patients around the world, 20,000 people of more than 100 nationalities are involved. 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 s svojimi strateškimi investicijami v Sloveniji ne gradi le tovarn, temveč prihodnost – za znanost, za ljudi in za globalno zdravstvo. Da bi to vizijo uresničili, potrebujemo zavzete, motivirane in srčne strokovnjake, ki bodo s svojim znanjem in predanostjo soustvarjali zgodbo uspeha.

Kot
Ekspert upravljanja kakovosti – skladnost (d/ž/m) na projektu za novo lokacijo za proizvodnjo in testiranje končnih aseptičnih bioinjektabilnih izdelkov na Brniku
boste odgovorni za izvajanje zahtevnejših nalog na področju kakovosti ter za zagotavljanje skladnosti z regulatornimi zahtevami in internimi standardi podjetja Sandoz|Lek. Vaše delo bo usklajeno s strokovnim področjem, zakonodajo, dobrimi praksami ter poslovnimi cilji. Prevzemali boste odgovornost za obvladovanje tveganj, pripravljenost na inšpekcijske preglede ter aktivnosti upravljanja kakovosti. Poleg tega boste vodili in usklajevali kompleksnejše interne in zunanje projekte.

Vaše Ključne Odgovornosti

• Zagotavljanje skladnosti vseh aktivnosti z veljavnimi dobrimi praksami (cGxP), zakonodajo, internimi predpisi ter integriteto podatkov.
• Priprava in odobritev operativnih postopkov za izvedbo aktivnosti v proizvodnji in kontroli kakovosti.
• Podpira pri kvalifikaciji komor in skladišč.
• Podpora pri kvalifikacijah in validacijah (procesov v proizvodnji in kontroli kakovosti vključno z validacijo čiščenja), vključno z načrtovanjem, svetovanjem in pregledom dokumentacije.
• Upravljanje sistemov kakovosti, vključno z dokumentacijo, notranjimi presojami ter spremljanjem skladnosti.
• Priprava, usklajevanje in spremljanje korektivnih in preventivnih ukrepov (CAPA) ter obvladovanje odstopanj in reklamacij.
• Priprava in podpora pri inšpekcijskih pregledih ter komunikacija z zdravstvenimi oblastmi in globalnimi presojevalnimi skupinami.
• Vodenje in sodelovanje pri kompleksnih lokalnih in globalnih projektih, strateških pobudah ter spodbujanje nenehnih izboljšav in operativne odličnosti.

Vaš Doprinos k Delovnem Mestu

• Visokošolska stopnja izobrazbe farmacevtske, biološke, kemijske, mikrobiološke ali druge ustrezne naravoslovne smeri.
• Minimalno 3 leta delovnih izkušenj na področju proizvodnje, razvoja ali druge strokovne izkušnje na področju kakovosti.
• Aktivno znanje angleškega in slovenskega jezika.
• Dobro poznavanje orodij Microsoft Office.

Kaj Nudimo
Zaposlitev 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 (DobroBit) ter dogodke, neomejene priložnosti za učenje in razvoj.

Možne lokacije dela:
Slovenija
(Ljubljana in Brnik)

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

preko spletne povezave.

Zakaj Sandoz in Lek?
Generična in podobna biološka zdravila so hrbtenica svetovne industrije zdravil. Pri zagotavljanju več kot 900 milijonov terapij s Sandozevimi zdravili bolnikom po vsem svetu, sodeluje ljudi več kot 100 narodnosti. 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 ter 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.