Specialist kontrole kakovosti za Laboratorijsko opremo

Job Description Summary

Job Description

600+ je število kosov laboratorijske opreme za katere na nivoju Lek d.d. skrbimo v skupini Kontrole kakovosti (QC).  

Pridružite se nam kot Specialist kontrole kakovosti za Laboratorijsko opremo in postanite del naše interdisciplinarne ekipe, kjer boste v sodelovanju z laboratoriji skrbeli za življenjski cikel računalniško podprte laboratorijske opreme.

Vaše ključne odgovornosti:

Vaše odgovornosti vključujejo, vendar niso omejene na:

• Zagotavljanje, da so vse dejavnosti v skladu s trenutnimi dobrimi praksami (cGxP), ter v skladu z integriteto podatkov. Izvajanje nadzora nad aktivnostmi v kontroli kakovosti.
• Načrtovanje, spremljanje in dokumentiranje kvalifikacijskih aktivnosti (IQ/OQ/PQ).
• Vzdrževanje evidence o statusu opreme, vključno z zgodovino servisov, kalibracij in popravil.
• Organizacija rednega in izrednega vzdrževanja v sodelovanju z dobavitelji in servisnimi ekipami.
• Zagotavljanje pravočasne kalibracije opreme ter vodenje ustrezne dokumentacije.
• Spremljanje pogodb in servisnih dogovorov.
• Koordinacija dostave, namestitve in zagona nove opreme.
• Vodenje ali podpora pri validaciji in kvalifikaciji nove opreme.
• Preiskovanje odstopanj, povezanih z delovanjem opreme, ter predlaganje korektivnih in preventivnih ukrepov (CAPA).
• Priprava in vzdrževanje SOP-jev, delovnih navodil.

Vaš doprinos k delovnem mestu:

• Visokošolska stopnja izobrazbe farmacevtske, kemijske ali druge naravoslovne smeri (VII. stopnja).
• Zanimanje za tehnične rešitve v laboratorijskem okolju.
• Pismenost v programih MS Word, MS Excel in MS PowerPoint.
• Aktivno znanje angleškega jezika in slovenskega jezika.
• Natančnost, organiziranost in sposobnost vodenja tehnične dokumentacije.
• Sposobnost sodelovanja z internimi in zunanjimi partnerji (serviserji, dobavitelji, IT podpora).
• Pripravljenost na učenje in uvajanje digitalnih orodij (npr. LIMS, CDS).
• Proaktivnost pri reševanju tehničnih izzivov in izboljšavah procesov.

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. 

Lokacija dela: Lendava, Slovenija

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

Prijave z življenjepisom slovenskem jeziku lahko oddate najkasneje do 30. novembra 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.  

#BIORampUp #Sandoz

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600+ is the number of laboratory equipment units that the Quality Control group (QC) Group takes care of at Lek d.d. Join our interdisciplinary team where we oversee the lifecycle of laboratory equipment in collaboration with laboratories.

Join us as a QC Specialist for Laboratory Equipment and become part of our interdisciplinary team where we work with laboratories to manage the lifecycle of computerized laboratory equipment.

Your key responsibilities:

Your responsibilities include, but not limited to: 

• Ensuring that all activities comply with current Good Practices (cGxP) and data integrity standards. Oversight of activities within Quality Control.
• Planning, monitoring, and documenting qualification activities (IQ/OQ/PQ).
• Maintaining records of equipment status, including service, calibration, and repair history.
• Organizing regular and ad-hoc maintenance in collaboration with suppliers and service teams.
• Ensuring timely calibration of equipment and maintaining appropriate documentation.
• Monitoring contracts and service agreements.
• Coordinating delivery, installation, and commissioning of new equipment.
• Leading or supporting validation and qualification of new equipment.
• Investigating deviations related to equipment performance and proposing corrective and preventive actions (CAPA).
• Preparing and maintaining SOPs and work instructions.

What you will bring to the role:

• University degree in pharmacy, chemistry, or another natural science field (Level VII).
• Interest in technical solutions within the laboratory environment.
• Proficiency in MS Word, MS Excel, and MS PowerPoint.
• Active knowledge of English and Slovenian.
• Accuracy, organizational skills, and ability to manage technical documentation.
• Ability to collaborate with internal and external partners (service providers, suppliers, IT support).
• Willingness to learn and adopt digital tools (e.g., LIMS, CDS).
• Proactiveness in solving technical challenges and improving processes.

You will 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: Lendava, Slovenia

We offer permanent contract with 6-month of probation period. You are kindly invited to submit your application in English language, including CV, by November 30th, 2025

Why Sandoz? 

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched on 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.  

#BIORampUp #Sandoz

Skills Desired