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
Managing Director & Owner
Projexia SPRL
Since March 2015
Freelancer
Rixensart
Belgium
- 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
- LABWARE LIMS Administration certification
- 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
- Customer and Result oriented, trough strong involvement into the business
LIMS Business Analyst - ROXIS
GSK
Since November 2014
Consultant
Rixensart
Belgium
- Give support to the ROXIS Business project leader and project manager in the context of ROXIS remediation Project.
- Be the single point of contact between IT and Business.
- Align IT improvements with the Business reality :
- Participate to initatives which impract ROXIS Systems (Workshops, Measure Business needs, Propose solution, Participate to URS definition...)
- Take part in Test protocols & Validation.
- Test new functionalities.
- Elabore user guides & provide training.
- Give support to end users.
- Take part in Test protocols & Validation.
- Ensure continuous support for current applications :
- Align specific data reduction models and IT developments :
- Participate to data reduction initiatives with a global view on impacts on ROXIS Systems.
- Help end users in URS definition.
- Help end users in Test Protocols definition.
- Test data reduction solution with an end to end process view.
- Participate to data reduction initiatives with a global view on impacts on ROXIS Systems.
- Align specific data reduction models and IT developments :
- Work with a compliant view
- Participate to Change Request Management.
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.
Corporate Analytical Services - G-LIMS Team Manager
UCB Pharma
February 2012
to March 2013
- Working with QA to ensure compliance, RA to ensure high quality and timely submission documentation.
- Provide robust and seamless system around e-Analytical tools (global SOP, Change Control, Development & Validation of interfaces with others systems)
- Ensure successful administration of the Team through staff performance management and financial objectives.
- Drive implementation & improvements of e-Analytical tools (Project Mgmt, Planing, quality & feasability, cost...)
- Management of the global G-LIMS Team (6 direct reports (Bel.) + 4 dotted reports (CH + USA))
Corporate Analytical Services - Local G-LIMS Administrator
UCB Pharma
July 2010
to January 2012
- Local e-analytical tool deployment following the program planning and local implementation and routine planning/activity.
- Role:
- Be the local LIMS Admin for Braine ans Slough sites
- Ensure the local development & implementation of any electronic Analytical tool and provide local support to the network as needed (QC's and Analytical Development lab's for Braine (Belgium) and Slough (UK)).
Associate Scientist
UCB Pharma
April 2010
to June 2010
- Design of Experiment (screening of parameters, optimization of chemical steps, modelling)
- Process modelling (Reactop software)
- Process Analytical Technologies (FT-IR, FBRM, PVM, RAMAN, online HPLC)
- Process Thermal Hazard Evaluation (Stoessel's Methodology - Calorimetry, DSC )
- Main expertises
- use of automated equipments and statistical tools
- Job description: Specialist in high technology tools for chemical process understanding and optimization by the
New technologies Scientist
UCB Pharma
June 2007
to March 2010
- Since 2008, I focus my work on Thermal Process Safety Evaluation (Stoessel Methodology)
- Provides support for the use of automated multi-reactors, high pressure multi-reactors, safety studies, use of analytical probes at lab and pilot-scale (PAT methodology), statistics and Design of Experiment (screening, optimization, statistical modelling) for Chemical Process Development and Industrialization activities.
New technologies Technician
UCB Pharma
January 2002
to May 2007
- Provides support for the use of automated multi-reactors, high pressure multi-reactors, safety studies, use of analytical probes at lab and pilot-scale (PAT methodology), statistics and Design of Experiment (screening, optimization, statistical modelling) for Chemical Process Development and Industrialization activities
Development Technician
UCB Pharma
September 1995
to December 2001
- Development and Industrialization of Chemical Process, from lab scale to validation at full scale in a pharmaceutical environment. Wide area of activities from Process Research, Development and scaling-up including cGMP synthesis for supply drug product development, stability studies, clinical trials and/or chemical process validation
Sécurité Thermique des Procédés Chimique
Powders: Their Properties & Processing
Technique de l'informatique
Industrial Chemistry
Pharmaceutical Solids : Essential Knowledge and Advanced Concepts
- Français
- English
- Business Analyst
- Project Management
- System Deployement
- Computer System Validation
- System Development : Testing & Debuging
- Data management
- Team Spirit
- Accountability
- Fast Learner
- Electrician
- Organic Chemistry
- Process Safety
- Crystallization & Polymorphism
- PAT
- Scale-up & Industralisation
- Process Validation
- GxP
- FDA Inspection
- Quality Control
- Microsoft Office
- Web design
- Linux / Ubuntu
- Open Office
- Visual Basic
- SQL
