Xavier Van Roy
BioPharma Business Analyst - Senior Consultant
52 years old
Driving License
Brussels Area Belgium
Professional Status
Freelancer
Open to opportunities
About Me
PERSONNAL OBJETIVE:
Take full benefit of my 19 years of experience in bio-pharma and my strong Laboratories Information Management System (LIMS) & e-analytics expertise to contribute to companies ‘s organization and process efficiency through optimal system integration, while focusing on quality assurance and compliance.
EXPERTISE:
STRENGTHS:
Take full benefit of my 19 years of experience in bio-pharma and my strong Laboratories Information Management System (LIMS) & e-analytics expertise to contribute to companies ‘s organization and process efficiency through optimal system integration, while focusing on quality assurance and compliance.
EXPERTISE:
- LABWARE LIMS Administration certification
- Project Management (Use of PMI Methodology)
- Computerize System Qualification (GAMP)
- Data & Knowledge management
- Process Thermal Hazard Evaluation (Stoessel’s Methodology)
- Process Analytical Technologies
- Scaling-up from laboratory to industrial scale, according to cGMP rules
STRENGTHS:
- Customer and Result oriented, trough strong involvement into the business
- Strategic Thinking (Analytical mindset – Creativity/Innovation)
- Listening
- Quick learner
- Interpersonal Skills
- Team Work Skills
Corporate QC Operational - LIMS Business Analyst
UCB Pharma
April 2013
to September 2014
- As Subject Matter Expert (Business LIMS Expert), be the key contact between Business and IT Support Team :
- Drive implementation & improvements of LIMS Process (Project Mgmt, Planing, quality & feasibility, cost...).
- Support Global Process Owner until solution implementation and maintain technically the system after Go Live.
- Support Global & Local Key Users during URS definition, validation phase (OQ/PQ) and business implementation (Post Go Live Activities)
- Permanent Member of the LIMS Change Advisor Board.
- As Global Process Owner (LIMS Administration and LIMS-SAP interface), be a Global Business Representative :
- Collect and challenge requirement with a global approach.
- Review and approbation URS and ensure adhesion of local business.
- Participate to validation phase (OQ/PQ), and guarantee adequacy with URS.
- After Go Live, challenge new business requests and ensure the consistency of these.
