CSV Specialist

• Support the development and validation of new and existing computer systems
• Supports computer system development projects
• Ensures new clinical computer systems have been assessed for GCP risks prior to implementation
• Reviews and approves agreed deliverables from computer system validation projects
• Works closely with IT Risk & Compliance team to ensure IT and GxP quality issues and requirements are managed effectively
• Participates in preparation and support activities for GxP-regulated computer systems during regulatory inspections
• Facilitates Level 2 assessments of the validation status
• Assess regulatory risk associated with computer systems and provide guidance on the management and mitigation of risk

• Qualified with a Bachelor’s degree in scientific discipline or equivalent
• Solid background (5 to 8 years) in development or validation of computer systems
• Knowledge of one or more of GLP/GCP/GMP/PV regulations
• Demonstrable knowledge of the regulated pharmaceutical industry and the computer compliance regulations
• Possess excellent planning and organizational skills
• Demonstrated effective problem solving and decision making
• Team player and autonomous
• Good command of English, French is a plus

• Challenging projects based on your interests and skills
• Personal follow-up and clear, transparent communication both before and after commencement of employment
• Possibility to follow extra training
• Inspiring network events and legendary after work drinks
• Strong network of industry leading clients
• Expertise within IT, Engineering and Life Sciences
• A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees

Bezoek pauwelsconsulting.com voor meer informatie over de vacature CSV Specialist of solliciteer online op de vacature CSV Specialist.

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