Ekspert tehnologije izdelkov III

Job Description Summary

#LI-Hybrid

Kot Ekspert tehnologije izdelkov III boste odgovorni za vsebinsko poznavanje izdelkov skozi življenjski cikel. Pri tem boste odgovorni 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, pri prenosu znanja in informacij med funkcijami ter lokacijami ter nudili boste strokovno podporo proizvodnji, skladno z zakonodajo, internimi predpisi, dobrimi praksami in poslovnimi cilji.

We are seeking a Product Steward III to own the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical variables, supports that the process(es) are robust, in continued state of validation and continuously improving. Supports in seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s). Provides second line technical/scientific process support, in accordance with legislation, internal rules, 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

· Podpira raziskavo temeljnih vzrokov za napake v procesih, sodeluje pri projektih za izboljšave izdelkov oz jih po dogovoru vodi,

· Pomaga pri definiranju kritičnih medprocesnih kontrol in parametrov sproščanja za posamezne izdelke (prenos QRA za posamezne izdelke)

· Skrbi za obdelavo podatkov in trendov ter za seznanjanje z njimi na nivoju proizvodnje.

Vaš doprinos k delovnem mestu:

· Univerzitetna diploma iz farmacije, farmacevtske tehnologije, kemije ali druge ustrezne znanstvene smeri.

· Zaželen magisterij iz omenjenih smeri.

· Aktivno znanje angleškega jezika

· Poznavanje orodja Microsoft Office

Z izbranim kandidatom bomo sklenili delovno razmerje za določen čas 1 leto, 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, 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:

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?

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:

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. 

Dostop in prilagoditve: V Novartisu si prizadevamo k vključenosti oseb z invalidnostjo in zagotavljanju ustreznih prilagoditev delovnega okolja posameznikom z omejitvami. V kolikor zaradi bolezni ali invalidnosti potrebujete ustrezne prilagoditve v kateremkoli delu selekcijskega procesa oziroma potrebujete prilagoditve pri izvajanju osnovnih nalog na delovnem mestu, nam pišite na naslov in navedite, kakšne prilagoditve potrebujete ter vaše kontaktne podatke. Prosimo, vključite tudi podatek o številki razpisa, na katerega se prijavljate. 

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Key Responsibilities:

· Maintain the oversight and knowledge for manufacturing process performed throughout the

· entire lifecycle, since transfer from development to date, act as SPOC.

· Create and maintain a product specific Quality Risk Analysis (QRAs).

· Monitor all critical variables as appropriate using statistical analysis.

· Review APQR and decide on quality of products

· 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.

· Assist in defining of critical In Process Controls (IPC) and release parameters (transfer of the product-specific QRA).

· Ensure data and trending are analyzed and communicated at shop floor level.

Essential Requirements:

· BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent

· scientific degree. Desirable MSc. or equivalent experience.

· Functional knowledge of English

· Knowledge of Microsoft Office

We offer temporary employment for 1 year 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, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Well-being), Unlimited learning and development opportunities.

Read our handbook to learn about all the ways we'll help you thrive personally and professionally:

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? /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:

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.

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 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. 

Skills Desired

Assembly Language, Change Control, Chemical Engineering, Chemistry, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge  , Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Pharmaceutics, Process and Cleaning Validation, Process Control, Process Engineering, Risk Management, Root Cause Analysis (RCA), Scheduler, Six Sigma, Sop (Standard Operating Procedure)

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