Plan and coordinate computer system validation (CSV) projects
Provide regulatory compliance and computer validation guidance and support
Create system validation deliverables (validation plan, user requirements, risk analysis, test protocols, validation reports) -Perform a risk analysis.
Plan and coordinate validation testing.
Responsible for validation documentation through approval and implementation.
Writing and reviewing of IQOQ protocols & reports, PQ protocols & reports.
ACHIEVEMENTS:
Ensure validated status of computerized systems, IT infrastructure and ERP systems in compliance with cGMP. (Ex: EBI R430)
Manage & prioritize business requests.
Ensure projects are managed in conjunction with all required cGMP regulatory standards (ex: Application to manage Validation of Excel Spreadsheets)
Generate validation documentation (protocols/reports) and provide assistance with execution of protocols for computerized systems. (Ex: Calibry system for Balance Mettler)
Investigate/troubleshoot moderately complex validation problems. systems (ex: Data integrity of multiple equipment and system).
CSV Consultant
Polypetide
07.2021 - 07.2022
Understanding of Software administration (user access, profile, network file extraction, network access, Audit trail, logs and reporting…)
Finding and proposal solution to resolve Data Integrity gap observed in different system (production system Excel file…)
Be able to prepare, plan and implement Data Integrity Solution.
Write qualification/validation documents activities depending on gaps resolution implemented.
Write quality documentation process (SOP, Form, Logbook,) to ensure future process to implement.
Follow-up data integrity project activities (CAPA PLAN) by a regular up to date of document.
Performs audit trail´s data integrity risk assessments.
Collaborated with cross-functional teams for identification and resolution of validation issues
CSV Consultant Support
Merck
01.2019 - 06.2021
Generate validation documentation (protocols/reports) and provide assistance with execution of protocols for computerized systems and equipment.
Responsible for validation documentation through approval and implementation.
Writing and reviewing of IQOQ protocols & reports, PQ protocols & reports
Audi /Vw Sales and Fleet Manager
Audi/VW
04.2007 - 04.2018
Strong analytical Skills
Financial Analyst, particularly focusing on budget management
Lead and coordinate the procurement activities for the New Car policy (LESAGE CAR TRADING)
• Understand and challenge the stakeholders needs through kick-off-meeting and workshops.
• Developing partnership with clients in order to purchase objective and requirements according to business needs.
• Overall responsibilities of the project from the maturation through to production & follow up the delivery and handover to the final customer with the Business Owner/Requestor.
People Manager: Technical and Project team
Budget and financial (leasing company) reporting to the CEO. Our Partners: EDENRED, SODEXO, AG Insurance.
Education
Certificat - CSV Consultant
A.Academy
Bruxelles
05.2020
Bachelor - Marketing Management
EFPME
Bruxelles
10.2011
BBA - Business Management
Ichec
Bruxelles
09.2010
High School Diploma -
ISJB
Bruxelles
09.2006
Skills
FUNCTIONAL KNOWLEDGE
SAP
Trackwise
Veeva Vault (Source) / Documentum
OSI PI System
SQL, PL/SQL
Banking & Financial market
DevOps environment
Invoicing & billing Telecom
Customs & customs rates
Accomplishments
4 YEARS EXPERIENCES
Data integrity CSV
Good knowledge of GAMP5, ASTM e2500 21 CFR part 11