Data & AI Consultant for Life Sciences & Pharma

3/2019 – 2/2020

The client contracted Capgemini as an implementation partner for its new global CRM suite, I was involved in the global process of core requirements collection and specifications development by conducting interviews with stakeholders and users from over 10 European countries to map the local processes and factor their specificities into the system, these processes involved:

 GxP critical processes pertaining to samples management and product supply,
 Pharmacovigilance signal detection and management
 Product technical complaints management,
 Exchange of value disclosure recording and reporting,
In addition to supporting the creation of core system validation documentation based on my process knowledge and user requirements.
In addition to my role on a global level I served as a project manager on a local level in the DACH region:

 I ensured proper representation of the region’s requirements on a global level and in the system’s core processes
 Ensured that local external and third-party service providers were properly integrated into the new system,
 I managed the involvement of all Business Units’ stakeholders and users,
 Arranged multi country product review workshops,
 Performed gap-fit analyses and oversaw testing preparations including use cases and test scripts creation,
 Closely monitored the progress of testing operations,
 Supported the creation of Audit Trails, SOPs, Business Continuity guidelines and training material.
 Supported the Computerized System Validation process and documentation creation.

GXP, SAP S/4HANA

3/2019 – 2/2020

The client contracted Capgemini as an implementation partner for its new global CRM suite, I was involved in the global process of core requirements collection and specifications development by conducting interviews with stakeholders and users from over 10 European countries to map the local processes and factor their specificities into the system, these processes involved:

 GxP critical processes pertaining to samples management and product supply,
 Pharmacovigilance signal detection and management
 Product technical complaints management,
 Exchange of value disclosure recording and reporting,
In addition to supporting the creation of core system validation documentation based on my process knowledge and user requirements.
In addition to my role on a global level I served as a project manager on a local level in the DACH region:

 I ensured proper representation of the region’s requirements on a global level and in the system’s core processes
 Ensured that local external and third-party service providers were properly integrated into the new system,
 I managed the involvement of all Business Units’ stakeholders and users,
 Arranged multi country product review workshops,
 Performed gap-fit analyses and oversaw testing preparations including use cases and test scripts creation,
 Closely monitored the progress of testing operations,
 Supported the creation of Audit Trails, SOPs, Business Continuity guidelines and training material.
 Supported the Computerized System Validation process and documentation creation.

GXP, SAP S/4HANA