Profilbild von Astrid DrSanders Validation Lead, Project Manager aus Delmenhorst

Astrid Dr. Sanders

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Letztes Update: 08.09.2022

Validation Lead, Project Manager

Firma: Sanders & Associates GmbH
Abschluss: PHD - Dr.
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: deutsch (Muttersprache) | englisch (verhandlungssicher) | französisch (Grundkenntnisse)

Skills

Project Management, PMO, Computer System Validation, QMS, CSV, QA, GMP, Annex 11, CFR 21 Part 11, SOX, PMI, PMO, ITIL®, GAMP®, SOP, communication, Track & Trace, Serialisation

Projekthistorie

Company: Sanders & Associates GmbH
Position: Managing Director
 
Key focus of activities
  • IT Project  and Program Management
  • IT Computerized System Validation
  • Change Management / organizational changes
  • Business/IT Processes optimization
  • Communication / Coaching
  • Quality Management System
  • Project  and Program Controlling

Company: Tatkraft – Dr. Astrid Sanders
Position: Independent Consultant
 
Key focus of activities
  • Track & Trace
  • Project Leadership and Management
  • Computerized System Validation
  • Quality Management
  • Compliance /QA Auditor
  • QA Interim Management
  • Business/IT Processes optimization
  • Communication / Coaching
  • Change management and organizational changes
  • Quality Management System and Manuals

Sabbatical
Company: sanofi-aventis
Position: Deputy Director IT Processes, Communication and Quality Management
Global responsibility / Managing executive / Member of global IT Management Board
 
Key focus of activities
  • Company standards (cGMP, SOX etc.)
  • Quality and Compliance Management (cGMP / SOX / ISO / ITIL)
  • Internal audit und follow-up / Management of external audit activities
  • Project Supervision (Methodology, Risk Management, Change Management, Quality Management)
  • Internal communication, team building, conflict management
  • Program and Project Management
  • Internal business process design
 
Key Achievements
  • Successful (in-time/in-quality/in-budget) global harmonization of working processes in the context of post-merger and implementation of a supporting IT system
  • Development and implementation of a common GMP compliant Quality Management System
  • Project supervision/coaching for more than 200 IT projects in 2007
  • Development and execution of GMP compliance training
  • Established efficient internal communication and collaboration
  • Successful implementation of GMP and best practice related audit program
  • Approved SOX, GMP compliance by external auditors

Company: sanofi-aventis
Position: Manager - Strategy, Portfolio and Quality Management
Global responsibility / Managing executive / Member of global IT Management Board
Key focus of activities
  • Quality Management System (ISO 9000:2000 / 9001:2000 / GMP/ ITIL)
  • IT strategy und project portfolio management
  • Post-merger Communication
  • Contractor‘s Management
  • Team management - 6 team members located in London, Frankfurt, Bordeaux, Kansas City
Key Achievements
  • Established efficient global team, their training and qualification
  • Development of the global IT strategy and implementation as basis of portfolio management
  • Established Quality Management System (ISO, GMP, ITIL)
  • Efficient communication in the context of the post-merger situation

Company: Aventis
Position: Manager - Quality and Compliance / GxP Validation Leader
Global Management position
Key focus of activities
  • Quality Management and Project Methodology
  • Training
  • Project supervision – Project Methodology, Risk and Change Management
  • Team Management - 2 team members located in Frankfurt
 
Key Achievements
  • Transfer of an global expert team into an global department
  • Training of appr. 350 individuals
  • Implementation of an standardized way of delivering projects
  • Implementation of a global Change Management Process

Company: KPMG Consulting AG (today: bearingpoint)
Position: first consultant / soon senior consultant
Global Business Process Redesign and SAP R/3 Implementation
Summary of activities: Change Agent in the context of the global SAP implementation / Training of end users / On-boarding events and project marketing / Content Management Website and project communication

Reisebereitschaft

Verfügbar in den Ländern Deutschland, Österreich und Schweiz
Profilbild von Astrid DrSanders Validation Lead, Project Manager aus Delmenhorst Validation Lead, Project Manager
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