摘要
Interni naziv pozicije / Internal Job Title: Višji ekspert upravljanja kakovosti - operacije / Senior QA Operations Expert
Ste pripravljeni ustvariti resničen vpliv tam, kjer je to najpomembnejše? Kot Vodja zagotavljanja sterilnosti boste ključni nosilec strategije na področju obvladovanja kontaminacije in aseptične odličnosti v vrhunskem, tehnološko naprednem proizvodnem okolju. S svojo strokovnostjo boste zagotavljali, da vsak sterilen izdelek dosega najvišje globalne standarde – da je varen, skladen s predpisi in dostavljen pravočasno. Pridružite se nam pri vodenju nenehnih izboljšav, mentoriranju ekip ter soustvarjanju procesov, ki vsak dan ščitijo zdravje in življenje bolnikov po vsem svetu.
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Ready to make an impact where it matters most? As Sterility Assurance Lead, you’ll be the driving force behind contamination control and aseptic excellence in a cutting-edge manufacturing environment. Your expertise ensures every sterile product meets the highest global standards, safe, compliant, and delivered on time. Join us to lead improvements, mentor teams, and shape processes that protect patients worldwide.
Relocation Support: This role is based in Ljubljana, Slovenia. Novartis is unable to offer relocation support: please only apply if accessible.
About the Role
Vaše ključne odgovornosti:
- Vodenje aseptičnega QA nadzora in supervisije aseptičnih procesov (Aseptic Process Simulation – APS).
- Zagotavljanje QA nadzora pri odstopanjih proizvoda/procesa, lokalnih in globalnih eskalacijah, spremembnih kontrolah in presojah ter zagotavljanje ustrezne eskalacije in sanacije kritičnih zadev, povezanih z aseptičnimi procesi.
- Vodenje in/ali sodelovanje v globalnih aseptičnih projektih, vključno z upravljanjem deležnikov na globalni ravni.
- Zagotavljanje nadzora in podpore na področju mikrobioloških vidikov proizvodnje, kot so monitoring okolja, monitoring plinov/vode in monitoring biološke obremenitve (Bioburden).
- Odobritev strategije obvladovanja kontaminacije za lokacijo ter zagotavljanje skladnosti z Aneksom 1 ter podpora pri njenem razvoju in implementaciji.
- Odgovornost za odobritev konceptualnih postopkov na področju aseptičnega vedenja in aseptičnih procesov ter zagotavljanje njihove implementacije in skladnosti z veljavnimi regulativnimi zahtevami.
- Zagotavljanje tehnične strokovnosti za tržne in klinične izdelke v regulatornih razpravah, pri pripravah na inšpekcijske nadzore ter pri regulatornih vlogah.
- Zagotavljanje QA nadzora ter podpora pri razvoju in izvajanju programov usposabljanja na področju mikrobioloških in aseptičnih najboljših praks z namenom krepitve kulture skladnosti in odličnosti.
Vaš doprinos k delovnem mestu:
- Univerzitetna izobrazba iz farmacije, biologije, mikrobiologije ali druge ustrezne naravoslovne oziroma tehnične smeri.
- Vsaj 5 let izkušenj v proizvodnji, razvoju ali drugih strokovnih funkcijah na področju kakovosti.
- Strokovnost na področju zagotavljanja sterilnosti in aseptičnih procesov v farmacevtski proizvodnji.
- Izkušnje z vodenjem preiskav odstopanj, validacij procesov in obvladovanjem sprememb v reguliranem okolju.
- Odlične sposobnosti sodelovanja in komunikacije ter sposobnost vplivanja na medfunkcijske time in deležnike.
- Tekoče znanje angleškega jezika.
Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev. Prijavo oddajte z življenjepisom v slovenskem in angleškem jeziku.
Ugodnosti in nagrajevanje:
Konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninska shema, možnost vključitve v kolektivno zdravstveno zavarovanje, shema nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju fizičnega in duševnega dobrega počutja ter delovne obremenitve (Polni življenja).), številne priložnosti za učenje in razvoj.
Preberite naš priročnik, da spoznate načine, s katerimi bomo spodbujali vaš osebni in profesionalni razvoj: https://www.novartis.com/careers/benefits-rewards
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.
Zakaj Novartis: Pomagati bolnikom in njihovim družinam zahteva več kot le inovativno znanost. Potrebna je skupnost zavzetih ljudi, kot ste vi. V Novartisu cenimo sodelovanje, podporo in navdihovanje drug drugega za razvoj prebojnih terapij, ki spreminjajo življenja pacientov. Ste pripravljeni ustvariti svetlejšo prihodnost skupaj z nami? https://www.novartis.com/about/strategy/people-and-culture
Pridružite se Novartisu: Ni pravo delovno mesto za vas? Prijavite se v našo bazo talentov, da ostanete v kontaktu z nami in se seznanite z ustreznimi kariernimi priložnostmi takoj, ko se pojavijo: https://talentnetwork.novartis.com/network
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Key Responsibilities
- Provide QA oversight and support microbiological/aseptic best practices training program development and execution to foster culture of compliance and excellence.
- Lead aseptic QA oversight and supervision of aseptic processing (Aseptic Process Simulation).
- Provide QA oversight for product/process deviations, local and global escalation, change controls and audits, ensuring escalation and remediation of critical issues related to aseptic processes.
- Lead and/or contribute to global aseptic projects including stakeholder management on a global level.
- Provide oversight and support of microbiological aspects related to manufacturing, such as environmental monitoring, gas/water monitoring, and Bioburden monitoring.
- Approve the Contamination Control Strategy for the site making sure it is compliant with the Annex 1 and support its development and implementation.
- Responsible for approving conceptual procedures in aseptic behavior and aseptic processes and ensuring their implementation as well as ensuring compliance with current regulatory requirements.
- Provide technical expertise for marketed and clinical products in regulatory discussions, inspection preparations and submissions.
Essential Requirements
- University degree in Pharmacy, Biology, Microbiology, or other equivalent natural or engineering science.
- Minimum 5 years of experience in production, development, or other quality functions in an expert position.
- Demonstrated expertise in sterility assurance and aseptic processing in pharmaceutical manufacturing.
- Experience leading deviation investigations, process validation, and change control in regulated environments.
- Strong collaboration and communication skills; ability to influence cross‑functional teams and stakeholders.
- Fluency in English.
We offer permanent employment with 6 months of probation period. Submit your application with the CV in Slovenian and English language.
Benefits and Rewards:
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, possibility of joining collective health insurance scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical and mental well-being and managing workload (Well-being), 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.
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
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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.
Vodja zagotavljanja sterilnosti (m/ž/d) / Sterility Assurance Lead (m/f/d)
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