摘要
Kot Ekspert tehnologije izdelkov boste odgovorni za vsebinsko poznavanje izdelkov skozi življenjski cikel in za ohranjanje zmogljivosti procesov, vrednotenih s pomočjo statističnih analiz kritičnih parametrov. Pomagali boste pri tem, da so procesi robustni, v stalnem stanju validiranosti in neprestanih izboljšav. Pomoč na področju prenosa znanja in informacij med funkcijami ter lokacijami ter strokovna podpora proizvodnji, skladno z zakonodajo, internimi predpisi, dobrimi praksami in poslovnimi cilji.
As a Product Steward you will own the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintain the oversight on process capability, through data trending and statistical analysis of critical variables, support that the process(es) are robust, in continued state of validation and continuously improving. Support in seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s). Provide second line technical/scientific process support, in accordance with legislation, internal rules, good practices and business objectives.
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.
- 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
- Podpira raziskavo temeljnih vzrokov za napake v procesih, sodeluje pri projektih za izboljšave izdelkov oz jih po dogovoru vodi
- Ocenjuje vpliv tehničnih sprememb, ocenjuje njihovo tehnično izvedljivost ter določa obseg tehničnih serij, preverja tehnična tveganja in poslovne prednosti predlaganih tehničnih sprememb
- Odgovoren je za zagotavljanje stalne validiranosti (procesna validacija, kontinuirna validacija itd.) za izbrane izdelke.
- Zagotavlja potrebne podatke za tehnične aktivnosti pri lansiranju oz prenosu izdelka, pri tem pa se osredotoča na obstoječe znanje, z ustreznim dokumentiranjem in po potrebi s podporo lokaciji, ki izdelek sprejema .
- Sodeluje pri projektih za povečanje robustnosti in vzdržnosti izdelkov.
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Vaš doprinos k delovnem mestu:
- Univerzitetna izobrazba iz ustrezne znanstvene smeri
- Aktivno znanje angleškega in slovenskega jezika
- Poznavanje orodja Microsoft Office
- Odlične komunikacijske spretnosti in pozornost do podrobnosti
Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev.
Zakaj Novartis?
Naš namen je soustvarjati medicino za izboljšanje in podaljševanje življenja ljudi, naša vizija pa je postati najbolj cenjeno in zaupanja vredno farmacevtsko podjetje na svetu. Kako lahko to dosežemo? S pomočjo naših ljudi. Prav naši sodelavci nas vsak dan spodbujajo, da dosežemo svoje ambicije. Postanite del te misije in se nam pridružite! Več na spodnji povezavi: https://www.novartis.com/about/strategy/people-and-culture
Kaj nudimo:
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.
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 naši mreži Novartis:
V kolikor se ne prepoznate v zgornjem opisu delovnega mesta, vas vabimo, da se vpišete na spodnji povezavi v Novartisovo bazo talentov saj lahko tako vašo vlogo upoštevamo za podobne pozicije v prihodnosti: https://talentnetwork.novartis.com/network
English version
Key Responsibilities:
- Maintain the oversight and knowledge for manufacturing process performed throughout the entire lifecycle, since transfer from development to date, act as SPOC.
- Ensure inspection readiness for all process related aspects of assigned products.
- Evaluate product abiilty, trending, detect issues, ensure the implementation of appropriate actions.
- Support root cause investigation of process failures, collaborate in product improvement projects and lead projects based on a specific agreement.
- 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.
- Responsible for ensuring the continued validation (process vallidation, ongoing validation etc.) for selected products.
- Provide the necessary data for the technical activities involved in launching or transferring out product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed.
- Collaborate in projects to increase robustness and sustainability of products.
Essential Requirements:
- Scientific degree;
- Fluent in English and Slovene;
- Knowledge of Microsoft Office;
- Great communication skills and attention to details.
We offer permanent employment with 6 months of probation period.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn morehere: https://www.novartis.com/about/strategy/people-and-culture
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), 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
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
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.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
