摘要
Z veseljem napovedujemo ustanovitev novega obrata klinične proizvodnje v Sloveniji, namenjenega hitrejšemu odkrivanju inovativnih zdravil za bolnike po vsem svetu. Ne zamudite priložnosti, da se pridružite naši mednarodni ekipi.
Kot Višji ekspert za oskrbo boste del ekipe za klinično proizvodnjo na naši lokaciji za tehnične raziskave in razvoj v Mengšu, kjer boste v prvi vrsti odgovorni za obrat klinične proizvodnje.
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We are thrilled to announce the establishing of new clinical manufacturing facility in Slovenia, dedicated to accelerating the creation of innovative medicines for patients around the globe. Don’t miss the chance to join our international team.
As Senior Supply Expert you will be part of our Drug Product Clinical Manufacturing Team at our Technical Research and Development site in Mengeš and be primarily responsible for Clinical Manufacturing Plant.
About the Role
Vaše ključne odgovornosti:
- Zagotavljanje procesa upravljanja materialov za klinično proizvodnjo.
- Priprava ocene tveganja za nov material s kategorizacijo materiala, priprava specifikacije naročanja, usklajevanje izpolnjevanja predloge MARF, sprožitev nakupa, priprava končne specifikacije, sprožitev in spremljanje načrtov vzorčenja, spremljanje sproščanja materiala.
- Spremljajte kvalifikacijo dobavitelja in podpora za upravljanje dobaviteljev.
- Spremljanje statusa meteriala v SAP sistemu.
- Preiskave glavnih vzrokov odstopanj v klinični proizvodnji, povezane z materialom.
- Podpiranje neprekinjenega poslovanja z ocenjevanjem in podpiranjem upeljevanja alternativnih ponudnikov.
- Soustvarjanje okolja SOP v NVS in izvajanje SOP v skladu z zahtevami in posebnostmi klinične proizvodnje.
- Vključevanje in mentorstvo sodelavcev na področju oskrbe zdravil.
- Zagotavljanje tehničnega strokovnega znanja med regulativnimi inšpekcijskimi pregledi in zagotavljanje skladnosti z regulatornimi zahtevami.
- Medfunkcionalno sodelovanje v organizaciji in zunaj nje za uskladitev dejavnosti z organizacijskimi cilji, zlasti z zagotavljanjem kakovosti in prodajalci.
Vaš doprinos k delovnem mestu:
- Odgovornost za dodeljene naloge in zanesljivost.
- Interpretacija in vrednotenje analiz in ter opredelitev ustreznih ukrepov, ki jih je treba sprejeti.
- Sposobnost dela v skupini (konstruktiven in zanesljiv prispevek v skupinskem okolju) in v matričnem okolju. Vplivanje brez avtoritete.
- Samomotivacija, ki temelji na rezultatih, in motivacija drugih za doseganje izjemnih rezultatov, hkrati pa zagotavlja spoštovanje etičnih in pravnih načel, z nenehnim prizadevanjem za izboljšave.
- Predano osredotočenost na vse deležnike.
- Osredotočenost na kakovost: zagotavljanje izdelkov in storitev najvišje kakovosti, ki ustrezajo notranjim in zunanjim potrebam in zahtevam.
- 5 let izkušenj v dobavnih organizacijah, 3 leta izkušenj v farmacevtski industriji; temeljito poznavanje zahtev cGMP.
Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas 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: http://www.novartis.com/careers/benefits-rewards
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? http://www.novartis.com/about/strategy/people-and-culture
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: http://talentnetwork.novartis.com/network
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.
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Key Responsibilities:
- Contributing to the Material Management Process for Clinical Manufacturing.
- Prepare risk assessment for new material with categorization, Prepare Ordering Specification, Coordinate filling out the MARF template, Trigger Purchasing, Prepare Final Specification, Trigger and Monitor Sampling Plans, Monitor Release of Material.
- Monitor Supplier Qualification and Support Vendor Management.
- Monitor material status in SAP system.
- Lead Root cause investigations in Clinical Manufacturing related to Material.
- Support Business Continuty by assessing and supporting the establishment of second vendors.
- Co-creating SOP landscape within NVS and implementation of SOP according to Clinical Drug Product Manufacturing requirements and specifics.
- Onboarding and mentoring of associates in area of drug supply.
- Providing technical expertise during regulatory inspections and ensuring compliance with regulatory requirements.
- Cross-Functional Collaboration in and outside the organization to align activities with organizational goals, specifically Quality Assurance and Vendors.
Essential Requirements:
- Accountability: responsibility for assigned tasks and reliability.
- Decision Making: correct interpretation of analyses and evaluations and identifying appropriate measures to be taken.
- Ability to work in a team (constructive and reliable contribution in a group setting) and in a matrix environment. Influencing without authority.
- Results driven self-motivation and motivation of others to achieve outstanding results while ensuring adherence to ethical and legal principles, with a continuous drive for improvement.
- Customer focus as the highest priority.
- Quality focus: providing the highest quality products and services that meet the needs and requirements of internal and external customers.
- 5 years of experience in supply organizations, 3 years experience in Pharmaceutical Industry; thorough knowledge of cGMP requirements
We offer permanent employment 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: http://www.novartis.com/careers/benefits-rewards
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? http://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: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
