摘要
Kot Ekspert procesnih tehnologij I boste odgovorni za ključno ekspertno podporo proizvodnji za vsa vprašanja vezana na specifičnost procesa znotraj enega ali več proizvodnih korakov, z namenom zagotavljanja pravočasne izvedbe procesov, stalne izboljšave kakovosti in produktivnosti, izvedene v skladu s trenutno veljavnimi GMP smernicami, SP ter veljavnimi funkcijskimi standardi (npr. ZVO).
Izboljšuje obstoječe tehnologije in uvaja nove in inovativne procese.
Skrbi za prenos znanja in informacij med funkcijami ter proizvodnimi lokacijami ter nudi strokovno podporo proizvodnji, skladno z zakonodajo, internimi predpisi, dobrimi praksami in poslovnimi cilji.
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We are seeking a Technical Steward I. In this role, you will provide to the Site the specialist knowledge and expertise, as Subject Matter Expert (SME), of specific pharmaceutical processes or process technologies (e.g. Technical Steward for galenics, for film coating, biologics – upstream or downstream, etc). Oversees processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies, in accordance with legislation, internal rules, good practices and business objectives.
About the Role
Vaše ključne odgovornosti:
Poznavanje tehnologije in opreme:
- Deluje kot enotna kontaktna oseba za povezavo z globalno mrežo MS&T in z organizacijo za tehnični razvoj, za ustrezne globalne aktivnosti za opredelitev in uvajanje novih tehničnih standardov za obstoječe in nove tehnologije in opremo.
- Poseduje znanja o specifičnih tehnologijah procesov farmacevtske proizvodnje na lokalnem nivoju, vključno s pilotno proizvodnjo, povečanimi ali zmanjšanimi velikosti serij (scaleup ali scaledown), in načrtovanjem eksperimev (DoE).
- Sodeluje pri opredelitvi in izboru farmacevtske opreme s prispevanjem podatkov za uporabniške zahteve.
- V sodelovanju s tehničnim razvoje, drugimi lokacijami in globalno mrežo MS&T omogoča lažji prenos tehničnega znanja.
- Skrbi za potrebne interne primerjave v Novartisu ter zunanje v znanstvenem in akademskem okolju ter na ta način pospešuje in krepi znanje in izkušnje sodeavcev ter jih širi na ostale dele organizacije.
- Je notranji in zunanji znanstveni ekspert, ki poroča o znanstvenem/tehničnem delu in ga predstavlja na internih/zunanjih sejah/konferencah in objavlja v mednarodnih znanstvenih revijah, ki jih recenzirajo strokovnjaki s tega področja, vključno s patenti.
- Delo vzdržuje v stanju pripravljenosti na inšpekcijske preglede.
- Skrbnikom izdelkov pomaga pri pripravi ocen tveganj glede kakovosti.
- Pomaga pri pripravi splošnih postopkov za procesno enoto.
- Enoti Inženiring zagotavlja tehnično strokovno znanje za aktivnosti načrtovanja pri investicijskih projektih v zvezi s tehnologijami na področju, za katerega je odgovoren.
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. Tekoče znanje slovenskega jezika.
- Poznavanje orodja Microsoft Office
- Minimalno 5 let delovnih izkušenj pri podpori procesov na področju proizvodnje / proizvodne znanosti in tehnologije / tehničnega razvoja / kakovosti.
Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev. Prijavo oddajte z življenjepisom v slovenskem in angleškem jeziku.
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.
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Key Responsibilities:
- Act as the SPOC for the interface with global MS&T network and with technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new
- technologies and equipment.
- Owns the knowledge of specific pharmaceutical manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (DoE).
- Participate in the definition and selection of pharmaceutical equipment, through providing input to User Requirements.
- Collaborate with technical development, other sites and global MS&T network to facilitate transfer of technical knowledge.
- Assure that the necessary benchmark is done internally in Novartis, and externally in the scientific and academic environment, in order to stimulate and to extend the knowledge, increasing the know-how of the associates and expanding it to the rest of the organization.
- Be a recognized scientific expert internally and externally by reporting and presenting scientific/technical work at internal/external meetings/conferences and publish in peer reviewed international scientific journals including patents.
- Maintain their work in inspection readiness level.
- Support Product Stewards in creation of Quality Risk Assessments.
- Support creation of SOPs for Process Unit.
Essential Requirements:
- BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree. Desirable MSc. or equivalent experience.
- Functional knowledge of English. Fluent in Slovenian.
- Knowledge of Microsoft Office.
- Minimum 5 years’ experience in process support in manufacturing/ manufacturing science and technology/technical development/quality.
We offer permanent employment with 6 months of probation period. Submit your application with the CV in Slovenian and English language.
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 (Wellbeing), employment at Top SI Employer, 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.
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.