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Ekspert upravljanja kakovosti - operacije (m/ž/d) / QA Operations Expert (m/f/d)

AT Novartis
Novartis

Ekspert upravljanja kakovosti - operacije (m/ž/d) / QA Operations Expert (m/f/d)

Ljubljana, Slovenia

Summary

#LI-Hybrid

Zaradi našega razširjenega poslovanja in rasti podjetja iščemo novega sodelavca/sodelavko v QA ekipi na naši lokaciji v Ljubljani. Na tej lokaciji vzpostavljamo novo proizvodnjo za sterilne izdelke, opremljeno z najsodobnejšo tehnologijo. Prvi sestavljeni in pakirani sterilni izdelek bo proizveden naslednje leto.
Vabimo vas, da se nam pridružite v naši QA ekipi ter sodelujete pri vzpostavitvi nove proizvodnje za sterilne izdelke.

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Due to our expanding operations and company growth, we are seeking a new team member in the QA team at our location in Ljubljana. At this location, we are establishing a new production facility for sterile products equipped with state-of-the-art technology. The first assembled and packaged sterile product will be produced next year.

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We invite you to join our QA team and contribute to the establishment of the new production for sterile products.

About the Role

Vaše ključne odgovornosti:

  • Zagotavljanje, da so postopki sestavljanja in pakiranja končnih sterilnih izdelkov skladni z internimi in GMP predpisi.
  • Zagotavljanja kakovosti pri uvedbi novih izdelkov v proizvodnjo.
  • Pregled in odobritev kvalifikacijske, procesne in validacijske dokumentacije.
  • Upravljanje sprememb in odstopov.
  • Implementacija globalnih in regulatornih zahtev v interne postopke in sistem vodenja kakovosti.
  • Sodelovanje z globalnimi funkcijami, izmenjava znanja in izkušenj z drugimi lokacijami.
  • Vključenost v strateške aktivnosti, projekte, odločitve.
  • Vodenje priprav in sodelovanje na inšpekcijah.

Vaš doprinos k delovnem mestu:

  • Visokošolsko izobrazbo farmacevtske, kemijske, biokemijske, biotehnološke smeri ali druge podobne znanstvene discipline.
  • Najmanj 3 leta delovnih izkušenj na vsaj enem od naslednjih področjih v farmacevtski industriji: proizvodnja, MS&T, kakovost.
  • Ključna prednost so izkušnje na področju proizvodnje aseptičnih izdelkov in/ali kakovosti
  • Aktivno znanje angleškega jezika.

Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev.

Prijavo oddajte z življenjepisom v slovenskem in angleškem jeziku.

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.

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Key Responsibilities:

  • Assure assembly and packaging processes comply with internal and GMP regulations.
  • Provide QA support for the introduction of new products into production.
  • Review and approval of qualification, process and validation documentation.
  • Management of changes and deviations.
  • Implementation of global and regulatory requirements into internal procedures.
  • Collaboration with global QA functions, exchanging knowledge and experiences with other locations.
  • Involvement in strategic activities, projects, decision, assuring state of the art manufacturing processes.
  • Leading preparations and participating in audits.

Essential Requirements:

  • Education in the field of pharmacy, pharmaceutical technology, chemistry, chemical technology, biochemistry, biotechnology, or other relevant scientific discipline
  • Minimum 3 years of professional experience in one or more of the following areas in pharmaceutical industry: production, MS&T, quality.
  • Strong advantage is work experience in packaging of aseptic products and/or quality.
  • Active knowledge of the English language.

We offer permanent employment with 6 months of probation period. Submit your application with the CV in Slovenian and English language.

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 (Wellbeing), employment at Top SI Employer, 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.

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

Division
Operations

Business Unit
Innovative Medicines

Location
Slovenia

Site
Ljubljana

Company / Legal Entity
SI19 (FCRS = SI019) Novartis farmacevtska proizvodnja d.o.o.

Functional Area
Quality

Job Type
Full time

Employment Type
Regular

Shift Work
No

Client-provided location(s): Ljubljana, Slovenia
Job ID: Novartis-REQ-10030653
Employment Type: Full Time