摘要
Lokacija: Mengeš, Slovenija
Novartis se podaja na navdihujočo novo pot proizvodnje celične in genske terapije in išče izjemno motivirane posameznike, ki se nam bodo pridružili na tej poti k odličnosti. Iščemo strastne zaposlene, ki so pripravljeni prispevati svoj talent in soustvarjati naš uspeh. To je izjemna priložnost za sodelovanje v dinamičnih ekipah in soustvarjanje prihodnosti. V Novartisu iščemo odgovorno osebo za sproščanje inovativnih bioloških in genskih zdravil na trg, s ključno vlogo pri zagotavljanju skladnosti z zakonodajo in standardi kakovosti, ki bo omogočala nemoteno oskrbo pacientov z zdravili. Če vas navdihuje delo z neposrednim vplivom na zdravje in življenja ljudi in ste oseba zavezana osebni odličnosti z visokim nivojem integritete ter si želite poklicno in osebno rasti v dinamičnem delovnem okolju, vas vabimo, da se nam pridružite.
________________________________________________________
#LI-Hybrid
Location: Mengeš, Slovenia
Novartis is embarking on an inspiring new journey in cell and gene therapy manufacturing and is looking for highly motivated individuals to join us on this path to excellence. We are seeking passionate employees who are ready to contribute their talent and co-create our success. This is an exceptional opportunity to work in dynamic teams and help shape the future.
At Novartis, we are looking for a responsible person to release innovative biological and gene therapies to the market, playing a key role in ensuring compliance with legislation and quality standards, thereby enabling uninterrupted patient access to medicines.
If you are inspired by work that has a direct impact on people’s health and lives, and you are committed to personal excellence with a high level of integrity, and wish to grow professionally and personally in a dynamic work environment, we invite you to join us.
About the Role
Vaše ključne odgovornosti:
- Sproščanje inovativnih bioloških in genskih zdravil na trg skladno z direktivami EU, FDA ter lokalno zakonodajo, določili pogodb s partnerji in internimi postopki.
- Pregledovanje, preverjanje in ocenjevanje proizvodne ter analitske dokumentacije.
- Razvoj notranjega sistema kakovosti v skladu z dobro proizvodno prakso, zakonodajo in standardi Novartisa.
- Raziskovanje odstopanj v proizvodnji zdravil in predlaganje korektivnih ter preventivnih ukrepov.
- Priprava in revidiranje dokumentacije za nadzor kakovosti izdelkov.
- Obvladovanje reklamacij, potrjevanje letnih pregledov kakovosti, sprememb in izboljšav.
Vaš doprinos k delovnem mestu:
- Visokošolska izobrazba farmacevtske ali naravoslovne smeri
- Najmanj 3 leta izkušenj na področju sproščanja zdravil
- Dobro poznavanje slovenske zakonodaje o zdravilih
- Aktivno znanje angleškega jezika (pisno in ustno)
- Uporabniško znanje orodij Microsoft Office
- Zavezanost osebnemu in strokovnemu razvoju
Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev.
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 indružbenega počutja (Polni življenja) ter dogodki in 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.
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 diversity.inclusion_slo@novartis.com in navedite, kakšne prilagoditve potrebujete ter vaše kontaktne podatke. Prosimo, vključite tudi podatek o številki razpisa, na katerega se prijavljate.
____________________________________________________
Your Key Responsibilities:
- Releasing innovative biological and gene therapies to the market in accordance with EU directives, FDA regulations, local legislation, partner agreements, and internal procedures.
- Reviewing, verifying, and evaluating manufacturing and analytical documentation.
- Developing the internal quality system in line with Good Manufacturing Practices (GMP), legislation, and Novartis standards.
- Investigating deviations in drug manufacturing and proposing corrective and preventive actions.
- Preparing and revising product quality control documentation.
- Managing complaints, approving annual product quality reviews, changes, and improvements.
Your Contribution to the Role:
- University degree in pharmacy or a natural science discipline.
- At least 3 years of experience in drug release processes.
- Good knowledge of Slovenian pharmaceutical legislation.
- Proficiency in English (written and spoken).
- Proficient in Microsoft Office tools.
- Commitment to personal and professional development.
The selected candidate will be offered a permanent employment contract with a 6-month probation period.
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.
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 diversity.inclusion_slo@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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.
