摘要
Location: Ljubljana, Slovenija
Postani ključna oseba pri zagotavljanju robustnih procesov, v stalnem stanju validiranosti in neprestanih izboljšav zmogljivosti procesov, vrednotenih s pomočjo statističnih analiz kritičnih parametrov v MS&T kot Vodja validacij (m/ž/d). V tej vlogi boš vodil_a razvoj in izvajanje validacijskih strategij, ki so temelj za varno, učinkovito in skladno delovanje proizvodnih procesov. Prevzel_a boš odgovornost za razvoj, implementacijo in opravljanje procesnih validacij, validacij pakiranja, validacij čiščenja in revalidacij, skladno s časovnimi roki ter razpoložljivimi sredstvi. Pri tem boš zagotavljal_a skladnost z veljavno zakonodajo, dobrimi praksami, internimi predpisi, standardi kakovosti in zahtevami agencij za zdravila. Če te navdušuje delo v reguliranem okolju, kjer lahko s svojim strokovnim znanjem resnično vplivaš – potem je to priložnost zate.
___________________________________________
Become a key figure in ensuring robust processes, maintaining a constant state of validation, and continuously improving process performance, evaluated through statistical analysis of critical parameters in MS&T, as a Validation Lead (m/f/d). In this role, you will lead the development and implementation of validation strategies that form the foundation for safe, effective, and compliant manufacturing operations. You will take responsibility for the development, implementation, and execution of process validations, packaging validations, cleaning validations, and revalidations, in line with timelines and available resources. In doing so, you will ensure compliance with applicable legislation, good practices, internal regulations, quality standards, and regulatory agency requirements. If you are passionate about working in a regulated environment where your expertise can truly make an impact – then this is the opportunity for you.
About the Role
Vaše ključne odgovornosti:
- Razvijaj in izvajaj strategije validacije procesov, čiščenja, pakiranja in tekočega preverjanja.
- Zagotavljaj skladnost validacij z GMP, internimi predpisi, zakonodajo in standardi kakovosti.
- Vzpostavljaj in vzdržuj glavni načrt validacije ter spremljaj validacijski status lokacije.
- Pripravljaj validacijske protokole in dokumentacijo ter vodi validacijske aktivnosti.
- Svetuj pri ocenjevanju tveganj in izvajanju validacijskih strategij za nove izdelke.
- Sodeluj pri prenosih in lansiranjih izdelkov ter pripravi registracijske dokumentacije.
- Koordiniraj z oddelki za inženiring, IT, QC in AS&T pri kvalifikacijah in validacijah.
- Gostuj validacijske seje in zastopaj lokacijo v validacijski mreži.
- Skrbi za usposabljanje in razvoj sodelavcev ter upravljaj učne načrte.
- Podpiraj izvajanje Novartisovih proizvodnih praks in zagotavljaj trajnostno poslovanje.
Vaš doprinos k delovnem mestu:
- Zaključena visokošolska izobrazba naravoslovne, farmacevtske ali tehnične smeri.
- Izkušnje z validacijo procesov, čiščenja in pakiranja v reguliranem okolju.
- Dobro poznavanje zahtev dobre proizvodne prakse (GMP) in zakonodaje s področja zdravil.
- Sposobnost priprave validacijske dokumentacije in vodenja validacijskih aktivnosti.
- Izkušnje s sodelovanjem z različnimi oddelki (npr. IT, QC, inženiring) pri validacijah.
- Sposobnost ocenjevanja tveganj in uporabe orodij za upravljanje tveganj.
- Aktivno znanje angleškega jezika v pisni in ustni obliki.
Zaželeno:
- Aktivno znanje slovenskega 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
_____________________________________________
Key Responsibilities:
- Develop and execute validation strategies for processes, cleaning, packaging, and ongoing process verification.
- Ensure validation compliance with GMP, internal policies, legislation, and quality standards.
- Establish and maintain the site validation master plan and monitor validation status.
- Prepare validation protocols and documentation and lead validation activities.
- Advise on risk assessments and validation strategies for new product introductions.
- Participate in product transfers and launches and support registration documentation preparation.
- Coordinate with Engineering, IT, QC, and AS&T departments on qualifications and validations.
- Host validation board meetings and represent the site in the validation network.
- Support training and development of team members and manage training curricula.
- Support implementation of Novartis manufacturing practices and ensure business continuity.
What you will bring to the role:
- University degree in natural sciences, pharmacy, or technical field.
- Experience in process, cleaning, and packaging validation in a regulated environment.
- Strong knowledge of GMP requirements and pharmaceutical legislation.
- Ability to prepare validation documentation and lead validation activities.
- Experience collaborating with departments such as IT, QC, and Engineering.
- Risk assessment skills and familiarity with risk management tools.
- Fluent in English, both written and spoken.
Desirable Requirements:
- Fluent in Slovenian 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
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.
