Suchergebnisse: 54 Stellenangebote
60.600€ pro Jahr
Summary
As Senior QA Compliance Expert you will support, facilitate and drive on-site regulatory CMC related launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the Campus products to ensure timely...
Compliance
Teilzeitarbeit
Homeoffice
45.000€ pro Jahr
...gestalten.
Für unseren Standort in Niederndorf suchen wir zur Erweiterung des Teams ab sofort in Vollzeit eine/n:
Technical Compliance Manager (m/w/d)
Das Team
Die Aufgaben der Abteilung für Produktkonformität sind vielfältig und zielen auf verschiedene...
Compliance
Vollzeit
Reisebereitschaft
60.212,18€ pro Jahr
...About the role
Regulatory Affairs Manager (m/f/d), Sandoz, Kundl, Austria
Sandoz is going through an exciting and transformative... ...timelines and formal requirements, or assuring congruency and compliance
• You are an active member of the regulatory project (sub)team...
Compliance
PhD Position
Teilzeitarbeit
Homeoffice
...clinical concepts
Maintain, develop and update documents, reports, presentations and training materials and ensure compliance with all regulatory and company guidelines
Assess training needs and identify opportunities for continuous improvement in...
Compliance
Vollzeit
60.600€ pro Jahr
...aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the...
Compliance
Teilzeitarbeit
Homeoffice
60.212,18€ pro Jahr
...ensure execution of processes on-time (business continuity); in compliance to cGMPs, SOPs and applicable guidelines and functional... ...supporting documents and concepts, as well as for internal and regulatory inspections.
• Ensure real time shop floor support as an expert...
Compliance
Teilzeitarbeit
Homeoffice
60.212,18€ pro Jahr
...’ Sandoz!
1500! This is the average number of new submission Regulatory Affairs (Sandoz Small Molecule) does per year.
Global – this... ..., while assuring technical congruency and regulatory compliance, to obtain rapid and advantageous registrations of new products...
Compliance
Teilzeitarbeit
Homeoffice
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Reisebereitschaft(31)
SAP(41)
Homeoffice(93)
Schichtarbeit(71)
Einschulung(100)
Flexible Arbeitszeit(140)
Weiterbildung(209)
Lehre(98)
Mit Führerschein(156)
80.433,64€ pro Jahr
...manufacturing (concepts for sterile manufacturing processes, quality and compliance, project work, operational excellence, resources and budget/... ...Manufacturing Practices (GMP), customer service, statutory, regulatory and Novartis requirements
• Contribute to the achievement of...
Compliance
Teilzeitarbeit
Homeoffice
73.112,9€ pro Jahr
...initiatives to improve efficiency and output within the boundaries of aseptic manufacturing.
• Ensuring all the systems are in compliance with all Regulatory requirements
Role Requirements
What you’ll bring to the role:
Essential Requirements:
• Bachelor/Masters in...
Compliance
Homeoffice
108.430,28€ pro Jahr
...technical and people leadership for the Kundl site in all quality and cGMP
compliance related matters and ensure that all aspects of the operational business comply
with cGMP legal and regulatory requirements and Sandoz internal requirements.
Your key...
Compliance
Teilzeitarbeit
Homeoffice
108.430,28€ pro Jahr
...• Ensure manufacturing and operational excellence through adherence to all necessary quality, HSE, ethics & risk and compliance as well as regulatory requirements.
• Establish and maintain strong relationship with both Novartis internal and external stakeholders, in...
Compliance
...Ausbildung
Sie bringen mehrjährige Berufserfahrung in einer Bank (vorzugsweise in den Bereichen interne Revision, Risikomanagement, Compliance oder Prozessmanagement) oder bei einem Wirtschaftsprüfer mit
Sie verfügen über eine hohe IT-Affinität und haben Erfahrung...
Compliance
Ausbildungsplatz
Weiterbildung
Vollzeit
73.112,9€ pro Jahr
...system our patients cannot take their medicine. The global Device Compliance, Systems and Operations Team, part of Global Device &... ...similar Product Life Cycle Management system
• Knowledge of regulatory standards for medical devices and/or combination products....
Compliance
Teilzeitarbeit
Homeoffice
...protection, network security, client and server security, cloud security, interface security, security monitoring, security audit and compliance, IoT OT security, etc.
Provide security architecture advice and ensure the implementation of information and IT security...
Compliance
Vollzeit
60.212,18€ pro Jahr
...dich sein!
Zur Verstärkung des Teams suchen wir ab sofort in Kundl im Tiroler Unterland eine/n:
Regulatory Affairs Manager (m/w/d) - Regulierungsysteme / Compliance
Das Aufgabengebiet umfasst folgende Tätigkeiten:
Leitung und Unterstützung von Projekten/...
Compliance
Festanstellung
60.212,18€ pro Jahr
...control and fundamental understanding of applied statistics (MS-office, PI, Minitab, JMP)
• Understanding and oversight of relevant regulatory requirements, e.g. GMPs, ICH Q guidelines.
• Fluent in English and proficient in German
• Ability to act in a sophisticated...
Teilzeitarbeit
Homeoffice
51.686€ pro Jahr
...documentation of verification and validation tests
Documentation of the embedded software/firmware according to quality system and regulatory requirements
Coordination with the project leader
Technologien und Skills
C
C++
Bluetooth
Unsere Erwartungen an...
Ausbildungsplatz
Vollzeit
Flexible Arbeitszeit
66.800€ pro Jahr
...input to Justification of Specification (JoS) (from Device/PackTech and Human Factors Engineering (HFE))
• Contribute to and review regulatory documents, support product registrations incl. present at inspections.
Essential Requirements:
• Master or PhD in...
PhD Position
Teilzeitarbeit
Homeoffice
50.000€ pro Jahr
...Anforderungen der pharmazeutischen Industrie getestet werden. Unsere Kunden berätst du mit deiner Expertise bei ihren Fragen zu GMP Compliance der Produkte. Du sorgst dafür, dass unsere Ausrüstung und Herstellprozesse laufend qualifiziert und validiert werden, und...
Compliance
Vollzeit
...einschließlich Dokumentation
Unterstützung der Einrichtung von Qualitätsbetriebsprozessen
Durchführung routinemäßiger GxP-Compliance-/Betriebsaktivitäten gemäß den Novartis-Qualitätsstandards
Was Du für die Position mitbringst:
Abgeschlossene Fachausbildung...
Compliance
Ausbildungsplatz
Weiterbildung