Project Management (IT, Pharma) , Program Management & PMO Setup, Computerized System Validation, Business Process Modeling, Track & Trace
Aktualisiert am 23.05.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.06.2024
Verfügbar zu: 50%
davon vor Ort: 100%
Projektmanagement/Projektleitung
Computerized System Validation
Track & Trace
Serialisierung
Programmmanagement
Prozessmanagement
Deutsch
Muttersprache
Englisch
Verhandlungssicher
Russisch
Grundkenntnisse

Einsatzorte

Einsatzorte

Deutschland, Österreich
möglich

Projekte

Projekte

8 Monate
2022-08 - 2023-03

Global eQMS Implementation (Veeva Qdocs, Training, QMS)

Sr. IT Project Manager
Sr. IT Project Manager

Program management of the implementation of a global eQMS system.

Mainz
1 Jahr 4 Monate
2021-08 - 2022-11

SAP Solution Manager and S/4 HANA Validation

CSV Consultant
CSV Consultant

Elicititation and modeling of business processes in ARIS. Definition of  requirements for GxP-critical processes.

Management and execution of the Computerized System Validation for SAP Solution Manager (CHaRM) and  SAP S/4 HANA in GxP environment for an international company.


SAP SolMan S/4HANA
Aachen
7 Monate
2022-03 - 2022-09

Local eQMS Implementation

Senior Project Manager
Senior Project Manager

Project management of an implementation of a local eQMS implementation from initiation to closure.

Mainz
1 Jahr 5 Monate
2021-05 - 2022-09

Data Integrity Framework Implementation

Senior Project Manager
Senior Project Manager

Project management of the data integrity project from initiation to closure.


Mainz
10 Monate
2021-10 - 2022-07

Global eQMS System Selection

Senior Project Manager
Senior Project Manager

Project management of the initiation (process analysis, fit-gap, URS) and concept (RfP / system selection) phases for the implementation of a global eQMS system for an internationally acting group of companies.


Mainz
6 Monate
2021-05 - 2021-10

Pharmacovigilance System Implementation

Senior Project Manager
Senior Project Manager
Project management (ad interim) of the enhancements to processes and computerized system functionalities (SaaS) including CSV to improve pharmacovigilance processes for SARS-CoV2 vaccine.


Mainz
1 Jahr 4 Monate
2020-02 - 2021-05

Track & Trace: Implementation of an MAH

Serialization SME & CSV Consultant
Serialization SME & CSV Consultant
Implementation of a serialization project for a virtual MAH comprising GS1 registration, EMVO onboarding as SPoC, NMVO contracting, alignment and modeling of serialization business processes,  implementation, configuration and validation of TraceLInk LSC SaaS (Brand Owner & EU Compliance) as Level 4 / Level 5, and connections to Contract Packaging Organizations, Third Party Logistics and EMVS/EU hub.


Heerlen (The Netherlands)
2 Jahre 2 Monate
2019-02 - 2021-03

Track & Trace: Global Serialization Program

Program Management Consultant
Program Management Consultant

Analysis and restructuring of the program set-up. Support in RfP for future L4 system landscape consolidation (SAP OER / ATTP / TraceLink LSC) and Russia compliance. Revision of global validation strategy. Coaching of project management of global Russia compliance project. PMO set-up.

Indonesia and Ecuador Drug Traceability project management.
Bad Homburg vor der Höhe
1 Monat
2019-01 - 2019-01

Track & Trace: CMO Onboarding

Track & Trace Consultant
Track & Trace Consultant

Set-up of testing strategy (data tests, end-to-end tests, pilot batch) for the onboarding project of two international CMOs to the MAH via TraceLink (SNX / SOM) for EU FMD.


Jena
1 Jahr
2018-01 - 2018-12

Track & Trace: Program Manager for EU FMD Implementation

Program Management Manager
Program Management Manager

Program Track & Trace: Planning, design and implementation of regulatory requirements (e.g. USA DCSCA, EU Delegated Act 2016/161 / Falsified Medicines Directive, etc.) of Serialization, Aggregation and Tamper-Evident Packaging in a major German CMO biotechnology pharma manufacturing site. Management of the project across all ISA-95 levels as General Project Manager: Onboarding to MAHs via Level 5 (Tracelink and SAP ICH), Level 4 (SAP/ERP), Level 3/4 (Zeiser MedTracker), Level 2 (Wipotec-OCS line managers).

Dessau-Roßlau

Aus- und Weiterbildung

Aus- und Weiterbildung

10 Monate
2022-01 - 2022-10

ECA Computerised System Validation Manager

ECA Computerised System Validation Manager, Concept Heidelberg
ECA Computerised System Validation Manager
Concept Heidelberg
1 Jahr 4 Monate
2021-01 - 2022-04

TraceLink Track & Trace Services Administrator

Track & Trace Services Administrator, TraceLink
Track & Trace Services Administrator
TraceLink
1 Jahr 6 Monate
2016-01 - 2017-06

Projektmanagement-Zertifizierung

PMI-PMP (ID: 2047669), Project Management Institute
PMI-PMP (ID: 2047669)
Project Management Institute
3 Jahre 2 Monate
2004-04 - 2007-05

Dissertation

Doktor-Ingenieur, Otto-von-Guericke Universität Magdeburg
Doktor-Ingenieur
Otto-von-Guericke Universität Magdeburg
Software Engineering


4 Jahre 6 Monate
1999-10 - 2004-03

Informatik-Studium

Diplom-Informatiker, Otto-von-Guericke Universität Magdeburg
Diplom-Informatiker
Otto-von-Guericke Universität Magdeburg
Software Engineering


Position

Position

Projektmanagement / Programmmanagement / Computer-System Validierung / Prozessberatung



Branchen

Branchen

Pharma, IT

Einsatzorte

Einsatzorte

Deutschland, Österreich
möglich

Projekte

Projekte

8 Monate
2022-08 - 2023-03

Global eQMS Implementation (Veeva Qdocs, Training, QMS)

Sr. IT Project Manager
Sr. IT Project Manager

Program management of the implementation of a global eQMS system.

Mainz
1 Jahr 4 Monate
2021-08 - 2022-11

SAP Solution Manager and S/4 HANA Validation

CSV Consultant
CSV Consultant

Elicititation and modeling of business processes in ARIS. Definition of  requirements for GxP-critical processes.

Management and execution of the Computerized System Validation for SAP Solution Manager (CHaRM) and  SAP S/4 HANA in GxP environment for an international company.


SAP SolMan S/4HANA
Aachen
7 Monate
2022-03 - 2022-09

Local eQMS Implementation

Senior Project Manager
Senior Project Manager

Project management of an implementation of a local eQMS implementation from initiation to closure.

Mainz
1 Jahr 5 Monate
2021-05 - 2022-09

Data Integrity Framework Implementation

Senior Project Manager
Senior Project Manager

Project management of the data integrity project from initiation to closure.


Mainz
10 Monate
2021-10 - 2022-07

Global eQMS System Selection

Senior Project Manager
Senior Project Manager

Project management of the initiation (process analysis, fit-gap, URS) and concept (RfP / system selection) phases for the implementation of a global eQMS system for an internationally acting group of companies.


Mainz
6 Monate
2021-05 - 2021-10

Pharmacovigilance System Implementation

Senior Project Manager
Senior Project Manager
Project management (ad interim) of the enhancements to processes and computerized system functionalities (SaaS) including CSV to improve pharmacovigilance processes for SARS-CoV2 vaccine.


Mainz
1 Jahr 4 Monate
2020-02 - 2021-05

Track & Trace: Implementation of an MAH

Serialization SME & CSV Consultant
Serialization SME & CSV Consultant
Implementation of a serialization project for a virtual MAH comprising GS1 registration, EMVO onboarding as SPoC, NMVO contracting, alignment and modeling of serialization business processes,  implementation, configuration and validation of TraceLInk LSC SaaS (Brand Owner & EU Compliance) as Level 4 / Level 5, and connections to Contract Packaging Organizations, Third Party Logistics and EMVS/EU hub.


Heerlen (The Netherlands)
2 Jahre 2 Monate
2019-02 - 2021-03

Track & Trace: Global Serialization Program

Program Management Consultant
Program Management Consultant

Analysis and restructuring of the program set-up. Support in RfP for future L4 system landscape consolidation (SAP OER / ATTP / TraceLink LSC) and Russia compliance. Revision of global validation strategy. Coaching of project management of global Russia compliance project. PMO set-up.

Indonesia and Ecuador Drug Traceability project management.
Bad Homburg vor der Höhe
1 Monat
2019-01 - 2019-01

Track & Trace: CMO Onboarding

Track & Trace Consultant
Track & Trace Consultant

Set-up of testing strategy (data tests, end-to-end tests, pilot batch) for the onboarding project of two international CMOs to the MAH via TraceLink (SNX / SOM) for EU FMD.


Jena
1 Jahr
2018-01 - 2018-12

Track & Trace: Program Manager for EU FMD Implementation

Program Management Manager
Program Management Manager

Program Track & Trace: Planning, design and implementation of regulatory requirements (e.g. USA DCSCA, EU Delegated Act 2016/161 / Falsified Medicines Directive, etc.) of Serialization, Aggregation and Tamper-Evident Packaging in a major German CMO biotechnology pharma manufacturing site. Management of the project across all ISA-95 levels as General Project Manager: Onboarding to MAHs via Level 5 (Tracelink and SAP ICH), Level 4 (SAP/ERP), Level 3/4 (Zeiser MedTracker), Level 2 (Wipotec-OCS line managers).

Dessau-Roßlau

Aus- und Weiterbildung

Aus- und Weiterbildung

10 Monate
2022-01 - 2022-10

ECA Computerised System Validation Manager

ECA Computerised System Validation Manager, Concept Heidelberg
ECA Computerised System Validation Manager
Concept Heidelberg
1 Jahr 4 Monate
2021-01 - 2022-04

TraceLink Track & Trace Services Administrator

Track & Trace Services Administrator, TraceLink
Track & Trace Services Administrator
TraceLink
1 Jahr 6 Monate
2016-01 - 2017-06

Projektmanagement-Zertifizierung

PMI-PMP (ID: 2047669), Project Management Institute
PMI-PMP (ID: 2047669)
Project Management Institute
3 Jahre 2 Monate
2004-04 - 2007-05

Dissertation

Doktor-Ingenieur, Otto-von-Guericke Universität Magdeburg
Doktor-Ingenieur
Otto-von-Guericke Universität Magdeburg
Software Engineering


4 Jahre 6 Monate
1999-10 - 2004-03

Informatik-Studium

Diplom-Informatiker, Otto-von-Guericke Universität Magdeburg
Diplom-Informatiker
Otto-von-Guericke Universität Magdeburg
Software Engineering


Position

Position

Projektmanagement / Programmmanagement / Computer-System Validierung / Prozessberatung



Branchen

Branchen

Pharma, IT

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