Projects

Selected projects in reverse order:

October 2017 -
December 2018

Program Management
Track & Trace
(Life Sciences, DE)

Planning, design and implementation of regulatory
requirements (i.e. EU Delegated Act 2016/161 /
Falsified Medicines Directive, Korea, China) 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:
Level 4 (SAP/ERP), Level 3/4 (Zeiser MedTracker),
Level 2 (Wipotec-OCS line managers and devices).
Management of onboarding to MAHs via Level 5
(TraceLink and SAP ICH). 

January 2019

Serialization SME Consultancy
(Pharma, DE)

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. 

February 2019 -
March 2021

Track & Trace Program Management Consultancy
(Life Sciences, DE)

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.

February 2020 -
May 2021

Serialization SME & CSV Consultancy
(Life Sciences, NL)

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. 

February 2021 -
December 2021

Computerized System Validation
(Life Sciences, DE)

CSV of the enhancements to processes and computerized system functionalities (SaaS) to improve pharmacovigilance processes for SARS-CoV2 vaccine.

May 2021 -
October 2021

Project Management
(Life Sciences, DE)

Project management of the enhancements to
processes and computerized system functionalities
(SaaS) to improve pharmacovigilance processes for SARS-CoV2 vaccine.

June 2021 -
December 2021

Computerized System Validation
(Life Sciences, NL)

CSV of SAP Solution Manager (ChaRM) in a SAP S/4 HANA environment.

June 2021 -
today

TraceLink TTS Operation Support
(Life Sciences, NL)

Support of the operation of TraceLink Track & Trace Services.

July 2021 -
today

Project Management
(Life Sciences, DE)

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.

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