摘要
Naziv/Job Title: Specialist MS&T (m/ž/d) / MS&T Technical Specialist (m/f/d)
About the Role
Vaše ključne odgovornosti:
Vodenje preiskav odstopov v proizvodnji in rezultatov zunaj specifikacij z uporabo strukturiranih metodologij RCA. Sodelovanje s čezfunkcijskimi ekipami pri izvajanju CAPA ukrepov, preverjanj učinkovitosti in ocenjevanju kakovostnih tveganj. Upravljanje obravnave odstop ov in zagotavljanje pravočasnega zaključka v skladu z regulativnimi standardi. Podpora pripravljenosti na inšpekcijske preglede ter prispevanje k pripravam na notranje in zunanje presoje. Izvajanje in upravljanje validacijskih aktivnosti za procese, čiščenje in pakiranje v skladu s cGMP. Vzdrževanje in posodabljanje glavnih validacijskih načrtov ter zagotavljanje stalnega preverjanja ključnih parametrov. Priprava in pregled GxP dokumentacije, vključno s SOP-ji, spremembami in kvalifikacijskimi protokoli. Prepoznavanje in predlaganje izboljšav procesov za povečanje kakovosti, produktivnosti in operativne učinkovitosti.
Vaš doprinos k delovnem mestu:
Diploma iz farmacije, kemijskega inženirstva, biotehnologije ali sorodnih znanstvenih področij. Najmanj 4 leta izkušenj v MS&T, zagotavljanju kakovosti, regulativi ali proizvodnji farmacevtskih izdelkov. Dobro poznavanje obravnave odstopanj, preiskav incidentov in upravljanja CAPA ukrepov. Poznavanje okvirjev za oceno tveganja in regulativnih smernic za validacijo ter spremembe izdelkov. Odlične komunikacijske, predstavitvene in medosebne veščine v angleškem jeziku. Osnovno razumevanje nemškega jezika.
Z izbranim kandidatom bomo sklenili delovno razmerje za ne določen 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
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Your key responsibilities:
Lead investigations of deviations in production, and out-of-specification results using structured RCA methodologies. Collaborate with cross-functional teams to implement CAPAs, effectiveness checks, and quality risk assessments. Manage deviation handling and ensure timely closure in compliance with regulatory standards. Support inspection readiness and contribute to internal and health authority audit preparations. Execute and manage validation activities for processes, cleaning, and packaging in line with cGMP. Maintain and update master validation plans and ensure ongoing verification of critical parameters. Prepare and review GxP documentation including SOPs, change requests, and qualification protocols. Identify and propose process improvements to enhance quality, productivity, and operational efficiency.
What you will bring to the role:
Bachelor’s degree in pharmacy, chemical engineering, biotechnology, or related scientific discipline. Minimum 4 years’ experience in MS&T, Quality Assurance, Regulatory, or pharmaceutical manufacturing. Strong knowledge of deviation handling, incident investigations, and CAPA management. Familiarity with risk assessment frameworks and regulatory guidance on validation and product changes. Excellent communication, presentation, and interpersonal skills in English. Basic understanding of German language.
We offer permanent employment with 6 months of probation period.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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 (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. 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
Business Unit
Innovative Medicines
Company / Legal Entity
SI19 (FCRS = SI019) Novartis farmacevtska proizvodnja d.o.o.
Alternative Location 1
Slovenj Gradec, Slovenia
Functional Area
Technical Operations
Apply to Job
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]
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.