Compliance & Quality System Manager
1 mese fa
Samenvatting
~Beheer kosteneffectieve GxP Compliance- en/of Audit-activiteiten, -activiteiten en -systemen om ervoor te zorgen dat bedrijfsonderdelen voldoen aan de Novartis Quality Manual and Policies en alle relevante GxP-, wet- en regelgevingsvereisten, en door middel van interne audits, KPIs (Key Performance Indicators) en KQIs (Key Quality Indicators)
~ Leiden van de voorbereiding en het beheer van externe en bedrijfsaudits en inspecties van de gezondheidsautoriteit.
Verantwoordelijkheden
~ Toezicht en implementatie van kwaliteitsmanagementsysteem
~ Incident management
~ GxP Audit en inspectiebeheer
~ Regelgevend toezicht op de site (incl. Reg-CMC-facilitering)
~ Uitzonderingsbeheer
~ Kwaliteitsmanagement van leverancier (lokaal)
~ Kwalificatie en validatie
~ Naleving van de kwaliteit
~ Gegevensintegriteit en eCompliance
~ Site KPI / KQI onderhoud / rapportage
~ Lokaal wervingsproces initiëren en stimuleren
~ Lijn verantwoordelijkheid en dagelijkse walkthrough
~ OpEx-projecten leiden
~ Onderzoek naar afwijking, OOx, klachten
~ CAPAs definiëren en implementeren
~ Ondersteuning van overdrachtsprojecten en validatiestudies
~ Teamstatistieken bijhouden en ervoor zorgen dat KQI/KPI aan de vereisten voldoet
~ Tekst en ontwerp controleren en goedkeuren
~ HSE-incidentenrapportage en actieopvolging
~ Ondersteuning voor nieuwe apparatuur in bedrijf (OQ, PQ)
~ Definieer verbetergebieden in processen en producten
~ Planning en werkbelastingsbeheer van resources en capaciteit (personen en apparatuur)
~ Prestatie- en leiderschapsondersteuning voor een gespecialiseerd team
~ Zorgen voor de beschikbaarheid van apparatuur, chemicaliën en verbruiksartikelen, indien van toepassing
~ SOP-beoordeling en -revisie
~ Lokale training uitvoeren en de trainingsstatus controleren
~ Melding van technische klachten / bijwerkingen / scenario's voor speciale gevallen met betrekking tot Novartis-producten binnen 24 uur na ontvangst
~ Distributie van monsters voor het in de handel brengen (indien van toepassing)
Key Performance Indicators
~Beheer kosteneffectieve GxP Compliance- en/of Audit-activiteiten, -activiteiten en -systemen om ervoor te zorgen dat bedrijfsonderdelen voldoen aan de Novartis Quality Manual and Policies en alle relevante GxP-, wet- en regelgevingsvereisten, en door middel van interne audits, KPIs (Key Performance Indicators) en KQIs (Key Quality Indicators)
~ Leiden van de voorbereiding en het beheer van externe en bedrijfsaudits en inspecties van de gezondheidsautoriteit.
Werkservaring
~Functionele diepgang
~People Leadership
~Grensoverschrijdende samenwerking
~Projectmanagement
Skills
~Beheer van grote incidenten
~Controle
~Nalevingsgerichte audits
~Prestatie-evaluaties van werknemers
~Personeelsbeheer
~Qa (Kwaliteitsborging)
~GMP-procedures
~Gezondheidsautoriteiten
~Slimme risico's nemen
~Financieel inzicht
~Omgaan met ambiguïteit
~Zelfbewustzijn
~Continu leren
~Technologische expertise
~Besluitvormingsvaardigheden
~Samenwerking / Teamwork
~Communicatieve vaardigheden
~Probleemoplossend vermogen
~Doelgericht
~Logisch denken
~Leiderschap
~Wendbaarheid
~Zakelijke samenwerking
~Zakelijk inzicht
~Stakeholder Management
~Probleemoplossend vermogen
Taal
Engels
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