Ekspert upravljanja kakovosti za proces proizvodnje bioloških učinkovin (m/ž/d) / QA expert for the production process of biological agents (m/f/d)

Summary

Prinašamo življenjsko pomembna zdravila milijonom ljudi. Smo na stičišču najnovejših dosežkov medicinske znanosti in inovativne digitalne tehnologije. Vse kar počnemo je usklajeno z našo zavezo h kakovosti in zagotavljanju varnih učinkovin za bolnike. Naša zaveza kakovosti temelji na znanosti, prinašamo inovativnost in naše delo je usmerjeno k bolnikom. Ne glede na to, ali sodelujete v razvoju, proizvodnji, vzdrževanju, skladnosti ali analizi, bo vaš prispevek neposredno vplival na bolnike." Brez preverjanja in zagotavljanja kakovosti v vseh točkah procesa ne moremo zanesljivo graditi zaupanja bolnikov. Vam to poslanstvo predstavlja vrednoto?

Kot Ekspert upravljanja kakovosti za proces proizvodnje bioloških učinkovin skupaj z sodelavci zagotavljate, da se uresničujejo zahteve po skladnosti dobre proizvodne prakse. Vaša vloga vključuje pobudo, usklajevanje in izvajanje vseh potrebnih aktivnosti za doseganje skladnosti. V tej vlogi imate kot strokovnjak tudi svetovalno vlogo v zadevah GMP za vse zaposlene v vrednostnem toku.

We bring life-saving medicines to millions of people. We are at the crossroads of the latest advances in medical science and innovative digital technology. Everything we do is in line with our commitment to quality and to providing safe active substances for patients. Our commitment to quality is based on science, we innovate and our work is patient-centred. Whether you are involved in development, production, maintenance, compliance or analysis, your contribution will have a direct impact on patients. ” Without quality checks and quality assurance at all points in the process, we cannot reliably build patient trust. Do you value this mission?

As the QA expert for the production process of biological agents, you and your colleagues ensure that GMP compliance requirements are met. Your role includes initiating, coordinating and carrying out all necessary activities to achieve compliance. As an expert, you also have an advisory role on GMP matters for all employees in the value chain.

About The Role

Vaše ključne odgovornosti:

• Zagotavljanje uvajanja proizvodnje novih produktov, implementacije nove opreme, izboljšav in povečanja kapacitet proizvodnih procesov.
• Sodelovanje pri prenosu proizvodnih procesov iz razvoja ali drugih proizvodnih lokacij.
• Sodelovanje pri zagotavljanju rednih proizvodnih procesov.
• Sodelovanje pri iskanju rešitev in izboljšav ter uvajanju sprememb s sodelavci proizvodnje, MS&T (manufacturing science and technology) in ostalimi funkcijami.
• Zagotavljanje, da so vse dejavnosti v skladu s trenutnimi dobrimi praksami (cGxP), ter v skladu z integriteto podatkov.
• Odobravanje validacije/kvalifikacije procesov, opreme in sistemov ter vstopnih materialov.
• Vodenje priprav in sodelovanje pri pregledih ter inšpekcijskih nadzorih.
  
  

Vaš Doprinos k Delovnem Mestu

• Univerzitetna stopnja izobrazbe biotehnološke, farmacevtske, kemijske ali druge ustrezne naravoslovne smeri.
• Aktivno znanje angleškega jezika.
• Aktivno znanje slovenskega jezika.
• Izkušnje z orodji Microsoft Office.
• Najmanj 3 leta ustreznih delovnih izkušenj s področja kakovosti, analitike ali proizvodnje.
  
  

Zaželene Izkušnje

• Zažele izkušnje s koordinacijo timov.
  
  

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

Prijave z življenjepisom v angleškem in slovenskem jeziku lahko oddate preko spletne povezave.

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, 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

Key Responsibilities

• Ensuring introduction of new products into production, implementation of new equipment, improvements and increases in the capacities of production processes.
• Participation in the transfer of production processes from development or other production locations.
• Participation in ensuring regular production processes.
• Participation in finding solutions and improvements and introducing changes with colleagues from production, MS&T (manufacturing science and technology) and other functions.
• Ensuring that all activities comply with current good practices (cGxP) and data integrity.
• Approving the validation/qualification of processes, equipment and systems and input materials.
• Management of preparations and participation in audits and inspections.
  
  

Essential Requirements

• University degree in biotechnological, pharmaceutical, chemical or other relevant natural sciences.
• Active knowledge of English language.
• Active knowledge of Slovenian language.
• Experience with Microsoft Office tools.
• At least 3 years of relevant work experience in the field of quality, analytics or production.
  
  

Desirable Requirements

• Desirable experience in coordinating teams.
  
  

We offer a permanent employment, with 6 month of probation period.

You are kindly invited to submit your application in English language, including CV.

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, 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