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Job Description Summary
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Job Description
Vaše ključne odgovornosti:
Pregled in posodabljanje ocene tveganj glede kakovosti pred prenosom in validacijo ter po potrebi prilagajanje strategije kontrole.
Skrb za razpoložljivost vseh pomembnih tehničnih informacij in dokumentacije za validacijo.
Opredelitev predvalidacijske in validacijske strategije, vključno s procesom, čiščenjem, pakiranjem ter spremljajočimi raziskavami (npr. čas stanja očiščene/neočiščene opreme).
Koordinacija tehnične, registracijske in validacijske serije na lokaciji.
Pregled validacijskih protokolov in poročil.
Izvajanje lokalnega nadzora sprememb sistemov na lokaciji ter skrb za njihovo odobritev in zaključek.
Vzpostavljanje načrta projektov za lokacijo, priprava znanstveno utemeljene tehnične strategije s projektno ekipo, priprava načrtov za ravnanje v izrednih razmerah, opredeljevanje ovir ter predlaganje rešitev.
Ocenjevanje in načrtovanje potreb po virih na lokaciji ter pridobivanje soglasij vodstva za stroške projektov (npr. ekvivalenti polnega delovnega časa, stroški serij, investicije in zunanji stroški), strategije in časovni okvir.
Sestavljanje in vodenje projektne ekipe na lokaciji, določanje prioritet za projekte in seje projektne ekipe, koordinacija aktivnosti ter skrb za skladnost s smernicami.
Vaš doprinos k delovnem mestu:
Univerzitetna diploma farmacevtske, kemijske ali druge ustrezne naravoslovne smeri. Zaželen magisterij iz omenjenih smeri.
Zaželeno vsaj 5 let ustreznih izkušenj s področja farmacevtske proizvodnje.
Aktivno znanje angleškega jezika.
Poznavanje orodja Microsoft Office.
Z izbranim kandidatom bomo sklenili delovno razmerje za določen čas s poskusno dobo 6 mesecev.
Ugodnosti in nagrajevanje:
Konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninska shema, shema nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in fizičnega počutja (iniciativa Polni življenja), številne priložnosti za učenje in razvoj.
Preberite naš priročnik, da spoznate načine, s katerimi bomo spodbujali vaš osebni in profesionalni razvoj: https://www.novartis.com/careers/benefits-rewards
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 Novartisu: Ni pravo delovno mesto za vas? Prijavite se v našo bazo talentov, da ostanete v kontaktu z nami in se seznanite z ustreznimi kariernimi priložnostmi takoj, ko se pojavijo: https://talentnetwork.novartis.com/network
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Key Responsibilities:
Review and update quality risk assessments prior to transfer and validation, and adjust control strategies as needed.
Ensure the availability of all critical technical information and documentation for validation.
Define pre-validation and validation strategies, including process, cleaning, packaging, and related studies (e.g., hold time for cleaned/uncleaned equipment).
Coordinate technical, regulatory, and validation batches at the site.
Review validation protocols and reports.
Perform local oversight of system changes at the site and ensure their approval and closure.
Establish project plans for the site, prepare scientifically justified technical strategies with the project team, develop contingency plans, identify obstacles, and propose solutions.
Assess and plan resource needs at the site and obtain management approval for project costs (e.g., full-time equivalent resources, batch costs, investments, and external expenses), strategies, and timelines.
Assemble and lead the site project team, set priorities for projects and project team meetings, coordinate activities, and ensure compliance with guidelines.
What you will bring to the role:
University degree in pharmacy, chemistry, or another relevant natural science. A master’s degree in the mentioned fields is preferred.
At least 5 years of relevant experience in pharmaceutical manufacturing is desirable.
Proficiency in English.
Knowledge of Microsoft Office tools.
We offer temporary employment with 6 months of probation period.
Benefits and Rewards:
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, possibility of joining collective health insurance scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical and mental well-being and managing workload (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
Skills Desired
Applied Statistics, Change Control, Data Analytics and Digital, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process and Cleaning Validation, Process Control, Quality Compliance, Regulatory Compliance, Resilience and Risk Management, Technical Leadership, Technology TransferWant to know if this job is worth applying to?
