摘要
Are you ready to shape the future of quality in the pharmaceutical industry? As a QA Operations Specialist II (m/f/d), you will play a critical role in ensuring that our products meet the highest standards of quality and regulatory compliance. Your work will directly contribute to patient safety and the efficiency of our manufacturing processes. If you thrive in a fast-paced environment where quality is a core value, we want to hear from you.
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Ste pripravljeni soustvarjati prihodnost kakovosti v farmacevtski industriji? V vlogi Specialista za upravljanje kakovosti II – Operacije (m/ž/d) boste imeli ključno vlogo pri zagotavljanju, da naši izdelki dosegajo najvišje standarde kakovosti in skladnosti. Vaše delo bo neposredno vplivalo na varnost pacientov in učinkovitost proizvodnih procesov. Če vas motivira dinamično okolje, kjer je kakovost temeljna vrednota, vas vabimo, da se pridružite naši ekipi.
About the Role
Your key responsibilities:
- Provide QA oversight for all activities related to the Nitrosamine Taskforce
- Review and approve risk assessments and quality control reports
- Take ownership of country-specific assessments and collaborate with local teams
- Manage the documentation lifecycle (e.g., SOPs, protocols, coversheets)
- Support product owners in QA-related events, sampling, regulatory obligations, and remediation actions
- Conduct gap assessments based on new Health Authority guidelines
- Provide QA support to quality control laboratories
Your contribution to the role:
- Experience in quality assurance or pharmaceutical manufacturing
- Proficiency in English for professional communication
- Solid understanding of pharmaceutical regulations and industry guidelines
- High attention to detail, accountability, and quality mindset
- Ability to manage documentation independently and collaborate across functions
- Competence in risk assessment and regulatory interpretation
The selected candidate will be offered a 1 year temporary 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.
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Vaše ključne odgovornosti:
- QA nadzor nad vsemi aktivnostmi v okviru Nitrosamine taskforce
- Pregledovanje in odobravanje ocen tveganja ter poročil laboratorija za kontrolo kakovosti
- Prevzem odgovornosti za lokalne ocene tveganja in sodelovanje z lokalnimi organizacijami
- Upravljanje življenjskega cikla dokumentacije (npr. SOP-ji, protokoli, spremni listi)
- Sodelovanje z lastniki izdelkov glede QA dogodkov, vzorčenja, regulatornih zahtev in sanacij
- Izvajanje ocene skladnosti glede na nova regulatorna priporočila
- Podpora laboratorijem za kontrolo kakovosti
Vaš doprinost k delovnem mestu:
- Izkušnje na področju zagotavljanja kakovosti ali farmacevtske proizvodnje
- Dobro znanje angleškega jezika za poslovno komunikacijo
- Poznavanje zakonodaje in smernic v farmacevtski industriji
- Visoka stopnja natančnosti, odgovornosti in usmerjenosti v kakovost
- Sposobnost samostojnega dela in učinkovitega sodelovanja z različnimi deležniki
- Sposobnost presoje tveganj ter razumevanja regulatornih zahtev
Z izbranim kandidatom bomo sklenili delovno razmerje za določen čas enega leta 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.
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
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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
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.
