About the Role
Vaše ključne odgovornosti:
- Ravnanje v skladu z veljavnimi predpisi GxP, splošnimi postopki, ZVO, ISEC in drugimi smernicami Novartisa v laboratoriju.
- Sodeluje pri pripravi laboratorijskih navodil, splošnih postopkov, obrazcev ter jih vzdržuje.
- Podpora, kvalifikacija in kalibracija laboratorijske / pilotne opreme z ustrezno dokumentacijo. Časovno načrtovanje in izvedba rednega vzdrževanja.
- Prispeva k vrednotenju nove opreme.
- Vrednoti in uvaja najsodobnejše tehnologije (laboratorijske metode, tehnike), optimizira obstoječe metode, prispeva k razvoju novih metod in reproducira objavjene metode.
- Načrtuje, izvaja in dokumentira poskuse za dodeljene produkte iz naslova transferjev procesov, izboljšave procesov in validacije procesov.
- Sodeluje v aktivnostih prenosa tehnologij z laboratorijskega v industrijsko merilo, podpira validacijske aktivnosti.
- Načrtuje in izvaja poskuse v podporo poizkusni proizvodnji / prenosom metod ter dokumentira rezultate v ustreznih poročilih.
- Z načrtovanjem in izvajanjem poskusov, analizo podatkov in tolmačenjem rezultatov nudi podporo raziskavi temeljnih vzrokov odstopanj, OOS in OOT.
- Zagotavlja strokovno usposabljanje za osebje v proizvodnji, pri tem pa uporablja opremo v laboratorijskih in pilotnih objektih.
Vaš doprinos k delovnem mestu:
- Univerzitetna diploma ali magisterij kemijske, biološke, farmacevtske ali druge ustrezne naravoslovne smeri.
- Aktivno znanje angleškega in osnovno znanje slovenskega jezika.
- Poznavanje orodja Microsoft Office
Zaželene izkušnje:
- Predhodne izkušnje v vlogi kakovosti v farmacevtski industriji.
Z izbranim kandidatom bomo sklenili delovno razmerje za določen čas s poskusno dobo 6 mesecev.
Kaj nudimo:
Konkurenčen plačni paket, letni bonus, fleksibilen način dela, z možnostjo prilagajanja urnika in delom od doma, zaposlitev v podjetju s certifikatom TOP Employer, 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.
Predani smo raznolikosti in vključenosti
Novartis si prizadeva ustvariti izjemno, vključujoče delovno okolje in oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.
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Key Responsibilities:
- Comply with applicable GxP regulations, SOPs, HSE, ISEC & other Novartis Guidelines in the laboratory.
- Contribute to and maintain lab instructions, SOPs, templates, documentation of laboratory.
- Support, qualification and calibration of lab / pilot equipment with accompanying documentation, schedule and perform routine maintenance.
- Contribute to the evaluation of new equipment.
- Evaluate and implement state-of- the-art technologies (laboratory methods, techniques), optimize existing methods, contribute to new method development and reproduce published methods.
- Design, execute and document experiments (formulation / analytical tests ....) for products assigned in the context of process transfer, process improvement and process validation.
- Participate in Tech Transfer activities from laboratory to industrial scale, support validation activities.
- Plan and execute experiments to support production trials / method transfers and document results in reports.
- Support root cause investigation for deviations, OOS, OOT by designing and executing experiments, analyzing data & interpretation of results.
- Provide technical training to manufacturing personnel using equipment in laboratory and pilot facilities.
Essential Requirements:
- University degrees (BSc or MSc) from chemistry, biologics, pharma or any
other appropriate natural sciences
- Functional knowledge of English, proficient knowledge of Slovene
- Knowledge of Microsoft Office
Desirable Requirements:
- Previous experience in a quality role within the pharmaceutical industry
We offer temporary employment with 6 months of probation period.
You’ll receive:
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), employment at Top SI Employer, Unlimited learning and development opportunities.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Role Requirements
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
