Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 26.07.2023
Verfügbar zu: 70%
davon vor Ort: 40%
Good Distribution Practice
GDP responsible person
Qualitätssicherung
GxP
Deviation Management
Reklamationsmanagement
lean six sigma
Einsatzorte
Deutschland, Schweiz, Österreich
Projekte
Information Officer according to §56 Austrian Drug Law
GDP Responsible Person
Responsible for all quality agendas of Austrian affiliate
Local batch release
Creation and maintenance of QM and SMF
Lead for audits and inspections
Astellas Pharma Ges.m.b.H
? Global Safety Database oversight
? Safety Report (RMP, PSURs) writing
? PV partner and contract management
? Creation and maintenance of PSMF
? Lead for PV audits and inspections
CYATHUS Exquirere Pharmaforschungs GmbH
Responsible for all pharmacovigilance and quality issues within
the Austrian affiliate
Lead for GVP and GDP inspections by competent authorities
In charge of affiliate quality management system and Site
Master File
Management of local ICSRs and PQCs
Position
GSP responsible person and affiliate quality lead
Branchen
pharmazeutische Industrie
Einsatzorte
Deutschland, Schweiz, Österreich
Projekte
Information Officer according to §56 Austrian Drug Law
GDP Responsible Person
Responsible for all quality agendas of Austrian affiliate
Local batch release
Creation and maintenance of QM and SMF
Lead for audits and inspections
Astellas Pharma Ges.m.b.H
? Global Safety Database oversight
? Safety Report (RMP, PSURs) writing
? PV partner and contract management
? Creation and maintenance of PSMF
? Lead for PV audits and inspections
CYATHUS Exquirere Pharmaforschungs GmbH
Responsible for all pharmacovigilance and quality issues within
the Austrian affiliate
Lead for GVP and GDP inspections by competent authorities
In charge of affiliate quality management system and Site
Master File
Management of local ICSRs and PQCs
Position
GSP responsible person and affiliate quality lead
Branchen
pharmazeutische Industrie
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