GxP Consultant - Lab CSV

Work experience

Jan 2020 – present Nelissen GxP Consultancy, Berghem
As Independent contractor:
Delivery of Project Management, Consultancy Services and Interim Operational Management

Client: MSD Animal Health R&D IT
Operational:
• Operational Lead CSV Team (5-7 FTE)
• Develop/Improve Global Quality Handbook CSV & Data Integrity
• Support Global AH R&D IT TechOps
Projects:
• Global Project Lead – Windows 10 Migration
• Global Project Support/Co-lead – SDLC Remediation

Nov 2018 – Dec 2019 Rescop B.V. Eindhoven
Assigment as Senior IT & Equipment Compliance Consultant

Client: MSD Animal Health

• Consultant & Validation Officer Computerized Lab Systems

• Global R&D IT Harmonization Lab Computing



Apr 2018 – Nov 2018Rescop B.V. Eindhoven
As Operation Lead (14 FTE)
• Job interviews and onboarding of employees
• Engaged in personal development of employees
• Coaching of employees
• HR related tasks
• Monitor and act upon Key Performance indicators for employees and customer satisfaction

As Senior IT & Equipment Compliance Consultant
At client: MSD Animal Health
• Consultant & Validation Officer Computerized Lab Systems
• Global R&D IT Harmonization Lab Computing

Nov 2013 – Apr 2017Rescop B.V. Eindhoven
As Team Lead (7 FTE)
• Job Interviews and onboarding of employees
• Coaching of employees
• HR Related tasks

As Senior IT & Equipment Compliance Consultant
Client: MSD Animal Health
• Consultant & Validation Officer Computerized Lab Systems
Client: MSD Human Health, Oss
• Quality Officer IT Systems & Applications
Client: Boehringer-Ingelheim, Weesp
• Validation Manager SAP Validation. Infrastructure Qualification

As Trainer at the Rescop Academy
• GAMP Training
• Agile Validation
At clients: TEVA Pharma, Bilthoven Biologicals Philips Consumer Healthcare and University of Poitier

Nov 2011 – Nov 2013 MSD, Oss
Asset Manager Steriles production department
• Management of automated systems
• Qualification of production equipment
• Owner and manager of changes and deviations
• Author of Standard Operating Procedures
• Implementation of GxP critical investment projects
• Manage maintenance, calibration and validation activities
• Subject Matter Expert during internal and external audits

Mar 2011 – Nov 2011PharmaCell BV (Now part of Lonza), Maastricht
Quality Engineer
• Validation of automated and computerized systems
• Qualification (IQ/OQ/PQ) of lab and production equipment
• Coordination of cleanroom qualifications
• Warehousing conform GDP
• Author procedures and work instructions
• Implementation of GxP lab and production equipment

Skills
Project Management: Plan, Execute, Progress Reporting, Staffing
Assessment Tools: FMEA, RCA, Vulnerability Scanning, Information Risk
Regulations & GuidelinesGMP, GLP, GDP, ICH Q8-Q9-Q10, 21 Cfr Part 11, Eudralex 4, OECD
Information Technology: Word, Excel, OneNote, Teams, PowerPoint, TrackWise, LIMS. Document Management Systems, JIRA, Kneat
Coaching: Explore and exploit talents and strengths to the benefit of the (project) team
Operational Lead: Prioritize, organize, assign and monitor task execution. Prevent potential issues or resolve them. Build connections to all stakeholders. Create and maintain relationships.

Languages Dutch: Native
English: Excellent, conversation, reading and writing
Sports and interests: Road bike racing, listen to music, watching movies, computer gaming, cooking, hiking, reading

Profile Solution-oriented, pragmatic, creative, analytical, calm, decisive