Astrid Dr. Sanders verfügbar

Astrid Dr. Sanders

Validation Lead, Project Manager

verfügbar
Profilbild von Astrid DrSanders Validation Lead, Project Manager aus Delmenhorst
  • 27749 Delmenhorst Freelancer in
  • Abschluss: PHD - Dr.
  • Stunden-/Tagessatz: nicht angegeben
  • Sprachkenntnisse: deutsch (Muttersprache) | englisch (verhandlungssicher) | französisch (Grundkenntnisse)
  • Letztes Update: 08.09.2020
SCHLAGWORTE
PROFILBILD
Profilbild von Astrid DrSanders Validation Lead, Project Manager aus Delmenhorst
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
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