Andreas Zapf

Angestellt, Senior Consultant, INCONSULT GmbH

Duisburg, Deutschland

Fähigkeiten und Kenntnisse

Regulatory Information Management
Validierung vom Computersystemen
Agile Methoden
NeeS
Software Evaluation
Project Management
21 CFR Part 11
Documentum
Regulatory Requirements
Process Development
Regulatory Operations
IDMP
Submission Planning
docuBridge
Implementierung
GAMP5
Informationstechnologie
Submission Management
Document Management
Scrum
Beratung

Werdegang

Berufserfahrung von Andreas Zapf

  • Bis heute 1 Jahr und 2 Monate, seit Apr. 2023

    Senior Consultant

    INCONSULT GmbH

  • 4 Jahre und 6 Monate, Okt. 2018 - März 2023

    Director Regulatory Affairs GxP Systems Quality Management, Vigilance & EHS

    Fresenius Kabi

    - 01/2022 - Processes & QM IT Systems, Pharmaceuticals and Devices Division

  • 4 Jahre und 4 Monate, Juni 2014 - Sep. 2018

    Principal Consultant

    MAIN5 GmbH & Co. KGaA
  • 6 Jahre und 2 Monate, Apr. 2008 - Mai 2014

    Manager CAS & other Positions

    LORENZ Life Sciences

    04/2008 - 12/2011: Product Manager Product Management LORENZ docuBridge. Includes requirements engineering, product and release planning, coordination with other units as well as customers. 01/2012 - 12/2012: Process Improvement Project Analysis, re-design & implementation of business critical processes in a growing organization. 01/2013 - 05/2014: Manager Cloud Application Services Management of the CAS Team. Design, implementation, and operation of the Cloud Solution Platform & Service Delivery.

  • 2 Jahre und 5 Monate, Nov. 2005 - März 2008

    IT Coordination R&D

    STADA R&D GmbH

    IT Coordinator in STADA’s R&D Unit – Regulatory Affairs. Responsible for the definition, selection, implementation and operation of a computerized system to support Electronic Submissions to European and non-European Health Authorities.

  • 1 Jahr und 1 Monat, Okt. 2004 - Okt. 2005

    Senior Consultant, Pharma IT

    Lorenz Life Sciences

    Senior Consultant for Lorenz Archiv Systeme GmbH. Primary responsibility for business process analysis, system planning, integration and key customer management as well as supporting the development of various software packages in order to help Lorenz to provide value-adding software to its clients.

  • 3 Jahre und 9 Monate, Jan. 2001 - Sep. 2004

    Principal Consultant, Pharma IT

    Liquent

    Principal Consultant for Liquent Inc. Responsible for business process analysis, system planning, integration and key customer management.

  • 5 Jahre und 5 Monate, Aug. 1995 - Dez. 2000

    Software Development, Pharma IT

    Merck KGaA

    Multiple positions, finally Head of Development & System Design for Merck’s multi-site Documentum implementation targeted for 2001 rollout. Application Expert for Merck’s Core Dossier implementation project.

Ausbildung von Andreas Zapf

  • 2 Jahre und 9 Monate, Sep. 1992 - Mai 1995

    Business & Information Technology

    EDV Fachschule Wiesau

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

  • Ungarisch

    Grundlagen

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