QA senior manager (d/f/m) / Ekspert upravljanja kakovosti I (d/ž/m)

Job Description

QA senior manager (d/f/m)

Sandoz, of which Lek is also a part, is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Sandoz Slovenia QA team of highly motivated and skilled experts is looking for experienced, curious, inspiring associates to join our team to support development of complex generic pharmaceuticals (e.g. injectables & nasal sprays for Small molecules & Large molecules pipeline) for position: QA Senior Manager.

Your Key Responsibilities

Your responsibilities include, but not limited to:

• Responsible for the development of the internal quality system in accordance with the pharmaceutical laws and regulations, Good Pharmaceutical Practices, and Sandoz standards.
• Responsible for the creation of systemic and standard operating procedures in order to establish and provide a quality system.
• Responsible for reviewing and approving technical-technological documentation.
• Ensure training on Good Pharmaceutical Practices.
• Responsible for the conduct of internal auditing and external suppliers oversight (approval of suppliers, contract suppliers and contract manufacturing suppliers) and coordinating inspections.
• Approving of change requests, driving exception management, performing quality system reviews.
  
  

What You Will Bring To The Role

• University degree in Pharmacy, Chemistry, or another natural science.
• 5 years of experience in the field of quality, development or production.
• Active knowledge of English language.
• Knowledge of Microsoft Office.
  
  

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 (Energized for Life), Unlimited learning and development opportunities.

Possible job locations: Slovenia (Ljubljana)

We offer permanent contract with 6-month of probation period. You are kindly invited to submit your application in English language, including CV, by 05. 09.2025.

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

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Sandoz, katerega del je tudi Lek, je trenutno kot pionir in vodilni svetovni ponudnik trajnostnih generičnih in podobnih bioloških zdravil v vznemirljivem in preobrazbenem obdobju.

Ekipa Upravljanja kakovosti Sandoz Slovenija, sestavljena iz visoko motiviranih in usposobljenih strokovnjakov išče izkušenega, radovednega, navdihujočega sodelavca, da se pridruži naši ekipi pri razvoju kompleksnih generičnih farmacevtskih izdelkov (npr. injekcije & pršila za nos za male in velike molekule) na delovnem mestu: Ekspert upravljanja kakovosti I.

Vaše Ključne Odgovornosti

• Razvoj internega sistema kakovosti v skladu s farmacevtsko zakonodajo, dobrimi farmacevtskimi praksami in Sandozovimi standardi.
• Izdelava sistemskih in splošnih postopkov za vzpostavitev in zagotavljanje sistema kakovosti.
• Pregled in potrjevanje tehničnotehnološke dokumentacije.
• Skrb za izobraževanje o dobrih farmacevtskih praksah.
• Izvedba notranjih in zunanjih presoj sistema kakovosti (potrjuje dobavitelje, pogodbene dobavitelje in dobavitelje pogodbene proizvodnje) in vodenje inšekcijskih nadzorov.
• Obvladovanje sprememb, učinkovito vodenje timov kakovosti, pripravljanje in vodenje inšpekcijskih nadzorov.
  
  

Vaš Doprinos k Delovnem Mestu

• Visokošolska stopnja izobrazbe farmacevtske, kemijske ali druge naravoslovne smeri
• 5 let delovnih izkušenj s področja kakovosti, razvoja ali proizvodnje
• Aktivno znanje angleškega jezika Poznavanje orodja 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 (Polni življenja) ter dogodke, neomejene priložnosti za učenje in razvoj.

Možne lokacije dela: Slovenija (Ljubljana)

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 05. 09.2025 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.

#Sandoz