Vaše ključne odgovornosti:

• Odgovorni ste za prenos tehnologije proizvodnje bioloških učinkovin na lokaciji.
• V sodelovanju z drugimi deležniki izdelate oceno tehnične izvedljivosti za odločitev o lokaciji oskrbe, določa obseg in strategijo tehničnih serij za prenos, pripravlja splošno projektno strategijo in projektni načrt, vključno z viri in časovnim okvirom. Sprožite in nadzirate postopek za lokalni nadzor sprememb povezanih s prenosom tehnoloških procesov.
• V primeru pogodbenega sodelovanja zagotavljate skladnost procesov tehnoloških prenosov s pogodbami o kakovosti in poslovnem sodelovanju.
• Oblikujete in vodite projektno ekipo na lokaciji, koordinirate dejavnosti projektne ekipe na lokaciji, povezujete strokovnjake obeh lokacij in poročate projektnemu vodstvu in vodstvu enote.
• Zagotovite pravočasno razpoložljivost tehnične dokumentacije. Izdelate in uskladite dokumente o prenosu proizvodnega procesa (protokol, poročilo).
• V sodelovanju z drugimi strokovnjaki pregledate in posodobite oceno tveganj kakovost (QRA) pred prenosom in pred validacijo, po potrebi prilagodite strategijo nadzora procesa. Pregledate prvi APQR po prenosu, da zagotovite ustrezno delovanje procesa in kvaliteto izdelka.
• Prispevajte k izboljšanju in optimizaciji procesov za prenose izdelkov.
• Zagotovite, da so na voljo vse ustrezne tehnične informacije in dokumentacija za validacijo.
• Koordinirate izdelavo tehničnih, regulatornih in validacijskih serij na lokaciji v skladu z opredeljeno strategijo validacije. Nudite podporo ekspertu validacij pri ustvarjanju validacijskega protokola in poročila.

Vaš doprinos k delovnem mestu:

• Univerzitetna diploma iz farmacije, farmacevtske tehnologije, kemije, biologije, biotehnologije, inženirskih ved ali drugega ustreznega znanstvenega področja. Zaželen je magisterij ali doktorat.
• Izkušnje pri vodenju tehnoloških projektov v proizvodnji ali razvoju, poznavanje GMP proizvodnje, izkušnje v biotehnološki proizvodnji ali drugih primerljivih industrijah ali institucijah (farmacevtska, živilska, kemijska industrija).
• Projektne vodstvene sposobnosti.
• Močne komunikacijske sposobnosti.
• Znanje angleškega jezika.

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, 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.

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:

• You are responsible for the transfer of technology for the production of biological substances at the location.
• In collaboration with other stakeholders, you create a technical feasibility assessment for the decision on the supply location, determine the scope and strategy of technical batches for the transfer, prepare the overall project strategy and project plan, including resources and timeline. You initiate and oversee the process for local change control related to the transfer of technological processes.
• In case of contractual cooperation, you ensure compliance of technology transfer processes with quality and business cooperation agreements.
• Form and lead the project team at the location, coordinate the activities of the project team at the location, connect experts from both locations, and report to the project management and unit management.
• Ensure the timely availability of technical documentation. You create and harmonize documents for the transfer of the production process (protocol, report).
• In collaboration with other experts, you review and update the quality risk assessment (QRA) before the transfer and before validation, adjust the process control strategy if necessary. You review the first APQR after the transfer to ensure proper process operation and product quality.
• Contribute to the improvement and optimization of processes for product transfers.
• Ensure that all relevant technical information and documentation for validation are available.
• Coordinate the production of technical, regulatory, and validation batches at the location in accordance with the defined validation strategy. You provide support to the validation expert in creating the validation protocol and report.

What you will bring to the role:

• A university degree in pharmacy, pharmaceutical technology, chemistry, biology, biotechnology, engineering, or another relevant scientific field is required. A master's or doctoral degree is preferred.
• Experience in leading technological projects in production or development, knowledge of GMP production, and experience in biotechnological production or other comparable industries or institutions (pharmaceutical, food, chemical industry).
• Project management skills.
• Strong communication abilities.
• Proficient in English language.

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 more here: 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, 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