Ekspert tehnologije izdelkov (m/ž/d) / Product Steward (m/f/d)

Job Description Summary

#LI-Hybrid
Lokacija/Location: Ljubljana, Slovenija
Relocation Support: This role is based in Ljubljana, Slovenia. Novartis is unable to offer relocation support: please only apply if accessible.

Pridružite se nam kot Ekspert tehnologije izdelkov (m/ž/d) in pomagajte soustvarjati medicino na naši novi proizvodni enoti Ljubljana Aseptika.

Imeli boste 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.

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Join us as a Product Technology Expert (m/f/d) and help co-create the future of medicine at our new Ljubljana Aseptic production site.

You will be responsible for in-depth product knowledge throughout the product lifecycle, as well as for maintaining process performance, evaluated through statistical analyses of critical parameters. You will contribute to ensuring that processes are robust, continuously validated, and constantly improved. In addition, you will be responsible for transferring knowledge and information across functions and locations, and for providing expert support to production in line with legislation, internal regulations, good practices, and business objectives.

Job Description

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 ali druge ustrezne znanstvene smeri. Zaželen magisterij iz omenjenih smeri.

• Minimalno 3 leta 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

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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 or equivalent scientific degree. Desirable MSc. or equivalent experience.

• Minimum 3 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

Skills Desired

Applied Statistics, Change Control, Data Analytics and Digital, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process and Cleaning Validation, Process Control, Quality Compliance, Regulatory Compliance, Resilience and Risk Management, Technical Leadership, Technology Transfer