Strokovni sodelavec za oskrbo zdravil (m/ž/d) / Associate Expert Drug Supply (m/f/d)

Salary Range:

€20,300.00 - €37,700.00

 

Job Description Summary

Z veseljem napovedujemo ustanovitev novega obrata klinične proizvodnje v Sloveniji, namenjenega hitrejšemu odkrivanju inovativnih zdravil za bolnike po vsem svetu. Najsodobnejši objekt, ki se nahaja v Biocampusu v Mengšu, nudi izjemno priložnost za sodelovanje, inoviranje in vpliv.

Iščemo navdušene in usposobljene strokovnjake za tim Kliničnih proizvodnih operacij. Kot strokovni sodelavec za oskrbo zdravil boste del tima Materialno poslovanje in obvladovanje vzorcev, ki podpira klinično proizvodnjo z zanesljivim, sledljivim in GxP-skladnim ravnanjem z materiali in vzorci.

Odgovorni boste predvsem za izvajanje dnevnih aktivnosti obvladovanja vzorcev in materialov, vključno s prevzemom, preverjanjem, shranjevanjem, pripravo, razdeljevanjem in odpremo vzorcev ter materialov, vodenjem dokumentacije, zagotavljanjem sledljivosti in sodelovanjem z notranjimi ter zunanjimi deležniki v skladu z internimi postopki, zahtevami GxP in načeli integritete podatkov.

Postanite del dinamičnega tima, ki na novo opredeljuje zdravljenje in prinaša upanje tistim, ki ga najbolj potrebujejo. Pridružite se nam pri oblikovanju prihodnosti varovanja zdravja in pri ustvarjanju pomembnih razlik v življenju bolnikov po vsem svetu. Veselimo se vašega prihoda v naš tim!
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We are thrilled to announce the establishing of new clinical manufacturing facility in Slovenia, dedicated to accelerating the creation of innovative medicines for patients around the globe. This cutting-edge facility, located at Biocampus Mengeš, offers unparalleled opportunities for collaboration, innovation, and impact.

We are currently looking to hire passionate and skilled specialists in the Clinical Manufacturing Operations team. As an Associate Expert Drug Supply, you will be part of the Material & Sample Management team supporting clinical manufacturing through reliable, traceable and GxP-compliant handling of materials and samples.

You will be primarily responsible for executing day-to-day sample and/or material management activities, including receipt, verification, storage, preparation, distribution and shipment of samples and materials, maintaining documentation and traceability, and collaborating with internal and external stakeholders in line with internal procedures, GxP requirements and data integrity principles.

Be part of a dynamic team that is reimagining medicine and delivering hope to those who need it most. Join us in shaping the future of healthcare and making a meaningful difference in the lives of patients worldwide. We look forward to welcoming you to our team!

Location: Menges, Slovenia
#LI-Hybrid

 

Job Description

Vaše ključne odgovornosti:

• Delovanje v skladu s standardi za kakovost, etiko, varnost, zdravje, okolje in informacijsko varnost ter zagotavljanje skladnosti z zahtevami GxP in integritete podatkov.
• Izvajanje dnevnih aktivnosti obvladovanja vzorcev in materialov za podporo klinični proizvodnji, vključno s prevzemom, preverjanjem, označevanjem, shranjevanjem, pripravo, distribucijo in odpremo.
• Zagotavljanje sledljivosti vzorcev in materialov v ustreznih sistemih, zapisnikih in dokumentaciji ter pravočasno in pravilno arhiviranje dokumentov.
• Priprava vzorcev za interno distribucijo, transport do laboratorijev ali zunanjih partnerjev, vključno s pripravo potrebne transportne dokumentacije in usklajevanjem posebnih zahtev.
• Izvajanje oziroma podpora pri alikvotiranju vzorcev, ravnanju z referenčnimi standardi, stabilnostnimi vzorci in retenzijskimi vzorci v skladu z odobrenimi navodili.
• Sodelovanje pri ravnanju z materiali na proizvodnem območju, vključno z naročanjem, prevzemom, preverjanjem ustreznosti, shranjevanjem in pripravo materialov za uporabo v proizvodnji.
• Uporaba in vzdrževanje ustreznih digitalnih orodij in sistemov za obvladovanje vzorcev in materialov, kot so SAP, LIMS/GLIMS ali druga lokalna orodja.
• Prepoznavanje, sporočanje in podpora pri obravnavi odstopanj, neskladnosti, temperaturnih odstopanj, napak v dokumentaciji ali drugih nepričakovanih dogodkov.
• Sodelovanje z notranjimi deležniki, kot so proizvodnja, QA,  analitika, planiranje in skladišča, ter z zunanjimi partnerji, kot so transportne službe, CRO in zunanji laboratoriji.
• Sodelovanje pri izboljšavah procesov, izmenjavi znanja, usposabljanju sodelavcev ter podpori notranjim in zunanjim presojam.

Vaš doprinos k delovnem mestu:

• Srednješolska izobrazba, zaželena je višja ali visokošolska izobrazba s področja farmacije, kemije, biotehnologije, logistike, naravoslovja ali drugega ustreznega področja.
• Tekoče znanje slovenščine. Tehnično znanje angleščine.
• Minimalno 1 leto izkušenj na primerljivem delovnem mestu v reguliranem, proizvodnem, laboratorijskem, logističnem ali skladiščnem okolju.
• Dobre organizacijske sposobnosti in sposobnosti upravljanja dokumentacije, zanesljivo vodenje evidenc ter razumevanje pomena sledljivosti in integritete podatkov.

• Sposobnost natančnega upoštevanja navodil, postopkov in časovno občutljivih aktivnosti.
• Ustrezno poznavanje programske opreme in računalniških orodij ter pripravljenost za delo v digitalnih sistemih za obvladovanje vzorcev in materialov.
• Sposobnost učinkovitega sodelovanja v timu, jasne komunikacije in prilagajanja spreminjajočim se prioritetam.

Zaželene izkušnje:

• Izkušnje z obvladovanjem vzorcev, materialnimi tokovi, skladiščenjem, distribucijo, transportno dokumentacijo ali laboratorijskimi procesi.
• Dobro poznavanje dobre proizvodne prakse (GMP), zahtev glede sledljivosti in dela v reguliranem proizvodnem ali laboratorijskem okolju.
• Izkušnje s sistemi za upravljanje z materiali in vzorci, kot so SAP, LIMS/GLIMS, ali z drugimi digitalnimi orodji za sledenje procesov.

Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev. Prijavo oddajte z življenjepisom v slovenskem in angleškem jeziku.

  

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Key Responsibilities:

• Working according to appropriate standards defined for quality, ethics, health, safety, environment, information security, and ensuring compliance with GxP and data integrity requirements.
• Executing daily sample and material management activities supporting clinical manufacturing, including receipt, verification, labeling, storage, preparation, distribution and shipment.
• Ensuring traceability of samples and materials in appropriate systems, logs and documentation, including timely and accurate archiving of records.
• Preparing samples for internal distribution, transport to laboratories or external partners, including preparation of required transport documentation and coordination of special requirements.
• Performing or supporting sample aliquoting, reference standard handling, stability sample handling and retain sample management according to approved instructions.
• Supporting shopfloor material management, including ordering, receipt, suitability checks, storage and preparation of materials for production use.
• Using and maintaining relevant digital tools and systems for sample and material management, such as SAP, LIMS/GLIMS or other local tracking tools.
• Recognizing, communicating and supporting the handling of deviations, discrepancies, temperature excursions, documentation errors or other unexpected events.
• Collaborating with internal stakeholders such as Manufacturing, QA, QC, Analytics, Planning and Warehousing, as well as external partners such as transport providers, CROs and external laboratories.
• Contributing to process improvements, knowledge exchange, training of colleagues, and support during internal and external audits.

Essential Requirements:

• High school education; higher education or university degree in pharmacy, chemistry, biotechnology, logistics, natural sciences or another relevant field is desirable.
• Fluent in Slovene. Technical knowledge of English.
• Minimum 1 year of experience in a comparable role in a regulated, manufacturing, laboratory, logistics or warehouse environment.
• Good organization and documentation skills, reliable record keeping and understanding of traceability and data integrity principles.
• Ability to accurately follow instructions, procedures and time-sensitive activities.
• Adequate knowledge of software and computer tools and willingness to work with digital systems for sample and material management.
• Ability to collaborate effectively in a team, communicate clearly and adapt to changing priorities.

Desirable Requirements:

• Experience with sample management, material flows, warehousing, distribution, transport documentation or laboratory processes.
• Solid knowledge of GMP, traceability requirements and work in a regulated manufacturing or laboratory environment.
• Experience with material and sample management systems, such as SAP, LIMS/GLIMS, or other digital process tracking tools.

We offer permanent/temporary employment with 6 months of probation period. Submit your application with the CV in Slovenian and English language.

Benefits & Rewards 

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. 

Expected Annual Base Salary Range for role: 20,300.00 to 37,300.00 EUR Annual

  

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

In addition to your base salary, you will be eligible for benefits listed below:  

• Annual bonus for all employees: 9% of annual base salary. 

• Holiday allowance: In 2025 it amounted to €2,496 (net). For 2026 it amounts to €2,678.28 (net). 

• Yearly performance-based bonus: In 2025 it amounted to €2,538.64 (gross), including the winter allowance. 

• Voluntary supplementary pension insurance: Novartis in Slovenia provides voluntary supplementary pension insurance (5.844% of gross salary, capped annually at €3,054.65). 

• Additional accident insurance: During employment at Novartis, the employee is insured 24/7 in the event of death or disability resulting from an accident.  

• Specialist insurance: Group health insurance providing faster access to specialist healthcare services at Triglav Health Insurance Company d.d. for you and your family members. 

• Care Connect: A program offering confidential, personalized support for mental health and well-being through therapy, counselling, tools, and more. 

• Other benefits in accordance with legislation and collective agreements: Transportation, meal allowance, and other supplements. 

Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf  

Accessibility and accommodation 

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Dostop in prilagoditve V Novartisu si prizadevamo k vključenosti oseb z invalidnostjo in zagotavljanju ustreznih prilagoditev delovnega okolja posameznikom z omejitvami. V kolikor zaradi bolezni ali invalidnosti potrebujete ustrezne prilagoditve v kateremkoli delu selekcijskega procesa oziroma potrebujete prilagoditve pri izvajanju osnovnih nalog na delovnem mestu, nam pišite na naslov [email protected]
 

 

Skills Desired

Capacity Planning, Continual Improvement Process, Materials Management, Project Planning, Supply Chain