摘要
Location: Ljubljana, Slovenija
Relocation Support: This role is based in Ljubljana, Slovenija. Novartis is unable to offer relocation support: please only apply if accessible.
Pridružite se ekipi, ki skrbi za najvišje standarde kakovosti in skladnosti v farmacevtski industriji! Kot Ekspert upravljanja kakovosti – skladnost, boste imeli ključno vlogo pri zagotavljanju, da naši procesi, izdelki in sistemi ustrezajo najstrožjim lokalnim in mednarodnim regulativnim zahtevam. Vaše delo bo neposredno vplivalo na varnost pacientov, učinkovitost proizvodnje in zaupanje v blagovno znamko Novartis.
Če vas navdušuje natančnost, strateško razmišljanje in sodelovanje z zdravstvenimi oblastmi, je to prava priložnost za vas.
_____________
Join a team that upholds the highest standards of quality and compliance in the pharmaceutical industry! As a Quality Management Expert – Compliance, you will play a key role in ensuring that our processes, products, and systems meet the strictest local and international regulatory requirements. Your work will directly impact patient safety, manufacturing efficiency, and trust in the Novartis brand.
If you are passionate about precision, strategic thinking, and collaboration with health authorities, this is the right opportunity for you.
About the Role
Vaše ključne odgovornosti:
- Zagotavljanje skladnosti z dobrimi praksami (cGxP) in integriteto podatkov v vseh aktivnostih.
- Komunikacija s kupci, vključno z usklajevanjem zahtev, sprememb in pregledom dokumentacije in globalnimi presojevalnimi skupinami.
- Upravljanje sistemov kakovosti, vključno z notranjimi presojami in dokumentacijo.
- Sodelovanje pri reševanju odstopanj v proizvodnji, laboratoriju ter koordinacija korektivnih in preventivnih ukrepov ter sledenje implementaciji.
- Podpora pri upravljanju sprememb, kvalifikacijah in validacijah ter svetovanje in pregled dokumentacije.
- Aktivno sodelovanje v internih in eksternih pregledih ter prispevanje k stalnemu izboljšanju sistemov kakovosti in skladnosti.
- Načrtovanje in izvedba letnih pregledov kakovosti izdelkov.
Vaš doprinos k delovnem mestu:
- Visokošolska izobrazba farmacevtske, biološke, kemijske, mikrobiološke ali druge ustrezne naravoslovne smeri.
- Najmanj 3 leta izkušenj na področju proizvodnje, razvoja ali kakovosti v farmacevtski industriji.
- Dobro poznavanje zakonodaje in regulativnih zahtev v Sloveniji in EU.
- Izkušnje z upravljanjem sistemov kakovosti in notranjimi presojami.
- Sposobnost samostojnega dela, natančnost in proaktivnost pri reševanju izzivov.
- Odlično znanje angleškega jezika v pisni in ustni obliki.
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: https://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? https://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: https://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 [email protected] in navedite, kakšne prilagoditve potrebujete ter vaše kontaktne podatke. Prosimo, vključite tudi podatek o številki razpisa, na katerega se prijavljate.
________________________
Key Responsibilities:
- Ensuring compliance with good practices (cGxP) and data integrity across all activities.
- Communication with customers, including alignment of requirements, changes, and documentation review, as well as with global audit teams.
- Management of quality systems, including internal audits and documentation.
- Collaboration in resolving deviations in manufacturing and the laboratory, coordinating corrective and preventive actions, and tracking their implementation.
- Support in change management, qualifications, and validations, including consulting and documentation review.
- Active participation in internal and external inspections, contributing to continuous improvement of quality and compliance systems.
- Planning and execution of annual product quality reviews.
Essential Requirements:
- University degree in pharmacy, biology, chemistry, microbiology, or another relevant natural science field.
- At least 3 years of experience in manufacturing, development, or quality within the pharmaceutical industry.
- Strong knowledge of legislation and regulatory requirements in Slovenia and the EU.
- Experience with quality system management and internal audits.
- Ability to work independently, with precision, and a proactive approach to problem solving.
- Excellent proficiency of English, both written and spoken.
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: https://www.novartis.com/careers/benefits-rewards
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
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 [email protected] 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.
