Job Description Summary
Location: Menges, Slovenia #onsite
Role Purpose:
V Novartis Slovenija uporabljamo inovativne znanstvene pristope in tehnologije za reševanje nekaterih najzahtevnejših zdravstvenih vprašanj v družbi. Odkrivamo in razvijamo prelomne terapije za zdravljenje bolezni, za katere je še vedno veliko neizpolnjenih potreb po zdravljenju.
Iščemo navdušene in usposobljene strokovnjake, ki bi se pridružili naši proizvodni ekipi v Klinični proizvodnji (Cx) Mengeš, ki je namenjena pospeševanju odkrivanja zdravil za paciente po vsem svetu. Kot višji ekspert za oskrbo zdravil boste del ekipe Kliničnih Proizvodnih Operacij (Cx MO).
Kot del naše ekipe boste primarno odgovorni za izvajanje dejavnosti, ki podpirajo proizvodni proces, kot so obvladovanje in nadzor pogojev okolja (čistih prostorov), podpora menjavi izdelkov in zagotavljanje skladnosti procesov s predpisi ter notranjimi postopki podjetja in zahtevami GxP.
Postanite del dinamične ekipe, ki na novo opredeljuje zdravljenje in prinaša upanje tistim, ki ga najbolj potrebujejo. Pridružite se nam pri oblikovanju prihodnosti varovanja zdravja in pri ustvarjanju pomembnih razlik v življenju bolnikov po vsem svetu. Veselimo se vašega prihoda v naš tim!
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In Novartis Slovenia we use innovative science and technology to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments, to treat diseases for which there is still a high unmet treatment need.
We are looking for enthusiastic and skilled professionals to join our manufacturing team at Clinical Manufacturing (Cx) Mengeš, dedicated to accelerating drug discovery for patients around the world. As a Senior Expert Drug Supply, you will be part of the Clinical Manufacturing Operations (Cx MO) team.
As part of our team, you will be primarily responsible for executing activities that support the manufacturing process, like environmental monitoring (cleanrooms), product change-over and ensuring compliance of processes with regulations as well as company internal procedures and GxP requirements.
Be part of a dynamic team that is reimagining medicine and delivering hope to those who need it most. Join us in shaping the future of healthcare and making a meaningful difference in the lives of patients worldwide. We look forward to welcoming you to our team!
Job Description
Ključne odgovornosti
- Ustvarjanje učinkovitih in široko segajočih postopkov ter spodbujanje njihove uvedbe.
- Gradnja in vzdrževanje močne mreže znotraj in zunaj organizacije za pridobivanje znanja, najboljših praks, izkušenj in ustvarjanje sinergij. Prepoznavanje težavnih in konfliktnih situacij, komuniciranje z vključenimi partnerji ali strankami ter empatično prispevanje k rešitvam.
- Vodenje upravljanja sprememb – Komuniciranje, naslavljanje in reševanje ključnih izzivov (npr. odstopanja in nepričakovani rezultati) ter drugih ključnih tem znotraj lastnega in širšega področja odgovornosti. Vodenje prenosa znanja ali postopkov drugim oddelkom ali zunanjim izvajalcem, vključno z odpravljanjem težav in usposabljanjem na terenu. Zagotavljanje izmenjave najboljših praks in znanja, medsebojna podpora v timu in širše ter zastopanje ekipe na ustreznih mestih.
- Podpiranje razvoja kulture v procesno usmerjeno organizacijo; vzor odgovornega, vključujočega, uspešnega delovanja, spoštovanja različnosti, zaupanja in nenehnega izboljševanja.
- Sodelovanje z zdravstvenimi organi, kjer je to primerno; delovanje kot tehnični strokovnjak na presojah s pomembnim prispevkom k notranjim (npr. GGA) in zunanjim presojam (npr. JAZMP).
- Samostojno načrtovanje, organizacija, izvajanje, nadzor, spremljanje in dokumentiranje dejavnosti Cx MO (vzorčenje čistih medijev, spremljanje pogojev okolja, čiščenje, certificiranje osebja, pretoka osebja in materialov, pregled dokumentacije, itd.). Izvajanje več dejavnosti hkrati z razumevanjem in izpolnjevanjem potreb strank ter zagotavljanjem, da so vse lastne in timske dejavnosti usklajene s celotnim proizvodnim procesom.
- Svetovanje na dodeljenem področju delovanja ter predlaganje izboljšav že uveljavljenih in jasno opredeljenih procesov. Prevzemanje odgovornosti za njihovo vpeljavo kot vodja ali član tima. Predlog in vpeljava izboljšav, novih metod, tehnologij ali drugih procesov za izboljšanje. Zagotavljanje ustreznega znanja za njihovo implementacijo in vzdrževanje.
- Ocenjevanje in interpretacija rezultatov ter samostojna priprava zaključkov. Strokovno in tehnično svetovanje, iskanje informacij, spodbujanje izmenjave znanja med zaposlenimi. Opravljanje kompleksnih nalog v GxP okolju. Kritično pregledovanje in odobritev izsledkov, ki so jih pripravili drugi.
- Druge naloge določene med letnim postopkom postavljanja ciljev in s kazalniki uspešnosti.
Vaš doprinos k delovnem mestu
- Visokošolska ali druga ustrezna stopnja izobrazbe iz farmacije, biokemije, biotehnologije, kemije, mikrobiologije ali druge ustrezne smeri.
- Najmanj 3 leta neposredno povezanih delovnih izkušenj kot strokovnjak v proizvodnji bioloških zdravil.
- Tekoče znanje slovenščine. Tehnično znanje angleščine.
- Ustrezno poznavanje programske opreme in računalniških orodij (npr. Microsoft Office).
- Poznavanje GxP ter dodeljenega Cx MO okolja (čisti prostori, osebni in materialni tokovi, itd.)
Želene izkušnje
- Poznavanje reševanja GxP odstopov in upravljanje GxP sprememb.
- Izkušnje z zagovori na internih in/ali zunanjih presojah.
Z izbranim kandidatom / kandidatko bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev. Prosimo, da oddate prijavo z življenjepisom v slovenskem in angleškem jeziku
Kaj nudimo
Konkurenčen plačni paket, letni bonus, fleksibilen način dela (z možnostjo prilagajanja urnika), možnost opravljanja dela od doma, pokojninska shema, shema nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in družbenega počutja (Polni življenja) zaposlitev v podjetju s certifikatom TOP SI Employer, 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
- Generating impactful and wide-reaching procedures and driving their implementation.
- Building and sustaining strong network in- and out-side the organization for knowledge gain, best practice, lessons learned, and synergies. Identifying issues and conflict situations, communicating to involved partners or customers and contributing with empathy to solutions.
- Driving change management - Communicating, addressing and solving key challenges (e.g. deviations and unexpected results) and other critical topics within own and broader area of responsibility; communicating effectively across organizational interfaces. Leading the transfer of know-how or procedures to other departments or external contractors, including troubleshooting and on-site training. Ensuring best practice sharing, knowledge exchange, and cross-functional support within the team and with other organizations and representing the team in corresponding meetings as needed.
- Supporting cultural evolution to a process-oriented organization. Role modelling a culture of accountability, diversity and inclusion, trust, high performance as well as continuous improvement.
- Interacting with health authorities where appropriate; acting as technical expert in audits and significantly contributing to internal (e.g. GGA) and external audits (e.g. JAZMP).
- Independently designing, planning, organizing, performing, supervising, monitoring and documenting Cx MO activities (sampling of clean utilities, environmental monitoring, cleaning, certification of personnel, personnel and material flows, review of documentation, etc.). Handling several activities at a time by understanding and meeting customer needs and ensuring all own and team activities are aligned with overall manufacturing process.
- Providing specific advice in own area and recommending improvements to well established and clearly defined processes. Accountable for improvement as leader or member. Proposing and implementing ideas, new methods, technologies or processes for continuous improvements.
- Critically reviewing, evaluating and interpreting results, drawing relevant conclusions independently. Providing scientific and technical guidance; performing information searches; actively fostering knowledge exchange within peer population. Performing complex tasks within GxP setup. Critical review and approval of findings prepared by others
- Other tasks as determined during the annual objectives setting process and by KPIs.
Essential Requirements:
- Bachelor’s degree or equivalent in Pharmacy, Bichemistry, Biotechnology, Chemistry, Microbiology or equivalent.
- Minimum 3 years of directly related experience as expert in biologics manufacturing.
- Fluent in Slovene. Technical knowledge of English.
- Adequate knowledge of software and computer tools (e.g. Microsoft Office).
- Knowledge of GxP and the assigned Cx MO environment (cleanrooms, personal and material flows, etc.)
Desirable Requirements :
- Knowledge of GxP deviation handling and managing of GxP changes.
- Experience in defending internal and/or external audits.
We offer permanent employment with 6 months of probation to the selected candidate. Please 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 of remote work, 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.
Skills Desired