摘要
Lokacija/Location: Mengeš, Slovenija
Pridružite se nam kot Ekspert tehnologije izdelkov I (m/ž/d) in postanite ključni člen pri oblikovanju prihodnosti farmacevtske odličnosti.
Kot Ekspert tehnologije izdelkov I (m/ž/d) boste imeli odgovornost za vsebinsko poznavanje izdelkov skozi življenjski cikel ter odgovornost za ohranjanje zmogljivosti procesov, vrednotenih s pomočjo statističnih analiz kritičnih parametrov. Sodelovali boste pri tem, da so procesi robustni, v stalnem stanju validiranosti in pri neprestanih izboljšavah. Poleg tega pa boste zadolženi tudi za prenos znanja in informacij med funkcijami ter lokacijami ter nudili strokovno podporo proizvodnji, skladno z zakonodajo, internimi predpisi, dobrimi praksami in poslovnimi cilji.
About the Role
Vaše ključne odgovornosti:
- Ohranja nadzor nad proizvodnim procesom izbranih izdelkov v celotnem življenjskem ciklu, od prenosa iz razvoja do tega trenutka, in vzdržuje ustrezno znanje.
- Pripravlja in vzdržuje analizo tveganja glede kakovosti za posamezne izdelke (QRA).
- S pomočjo statistične analize redno spremlja vse kritične spremenljivke za posamezne izdelke.
- Pregleduje APQR in sprejema odločitve glede kvalitete izdelkov.
- Zagotavlja pripravljenost na inšpekcijske preglede za vse procesne vidike izdelkov, ki so mu dodeljeni.
- Ocenjuje sposobnost izdelka, trende, zaznava probleme in skrbi za izvajanje ustreznih ukrepov.
- Ocenjuje vpliv tehničnih sprememb, ocenjuje njihovo tehnično izvedljivost ter določa obseg tehničnih serij, preverja tehnična tveganja in poslovne prednosti predlaganih tehničnih sprememb.
Vaš doprinos k delovnem mestu:
- Univerzitetna diploma iz farmacije, kemije, biokemije, biotehnologije ali druge ustrezne znanstvene smeri. Zaželen magisterij iz omenjenih smeri.
- Minimalno 5 let delovnih izkušenj pri podpori procesov na področju proizvodnje/proizvodne znanosti in tehnologije/tehničnega razvoja/kakovosti.
- Poglobljeno tehnično znanje, funkcionalna širina, medfunkcijske izkušnje.
- Aktivno znanje angleškega jezika.
- Poznavanje orodja Microsoft Office.
Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev.
Ugodnosti in nagrajevanje:
Konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninska shema, shema nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in fizičnega počutja (iniciativa 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.
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
_____________________________________________________________________________
English version:
Key Responsibilities:
- Maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date, act as SPOC.
- Create and maintain a product specific Quality Risk Analysis (QRAs).
- Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
- Review APQR and decide on state of control.
- Ensure inspection readiness for all process related aspects of assigned products.
- Evaluate product ability, trending, detect issues, ensure the implementation of appropriate actions.
- Assess impact of technical changes, assess their technical feasibility and determine scope of technical
batches, challenge technical risk and business benefit of technical changes proposed.
What you will bring to the role:
- BSc. in Pharmacy, Chemistry, Biochemistry, Biotechnology or equivalent scientific degree. Desirable MSc. or equivalent experience.
- Minimum 5 years experience in process support in manufacturing/manufacturing science and technology/technical development/quality.
- In-depth Technical Expertise, Functional Breadth, Cross-functional experience.
- Functional knowledge of English.
- Knowledge of Microsoft Office.
We offer permanent employment with 6 months of probation period.
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.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
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.
