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Global CSV Compliance Officer

Pauwels Consulting | Leuven | Permanent, Independent, Full-time

Published on Jobat.be 6 days ago

Pauwels Consulting is a Belgian consulting firm with more than 520 experts in engineering, life sciences and IT. We offer consulting, project management and recruitment services to leading companies in Belgium and beyond. We have offices in Belgium, France, Germany and Switzerland (https://www.pauwelsconsulting.com/about/contact/) .

Global CSV Compliance Officer

Job description

As Global CSV Compliance officer, you will be globally responsible for all CSV related activities especially within the transformation project. The project is a global internal project to implement SAP S4/HANA throughout the entire company.

  • Improve computer system compliance within the company Globally.
  • Ensures documentation and practices meet quality standards, applicable regulatory compliance and IS guidelines/policies.
  • Review user requirements, functional design specification, technical design specifications for clarity, Good documentation practices.
  • Review the accuracy and completeness of software validation deliverables created by the project functional process workstreams and the data migration, authorization and Infrastructure cross functional Project workstreams
  • Perform Validation and Qualification of GXP/Non GXP systems and infrastructure
  • Write and execute Computer System Validation (CSV) Protocols and Validation Summary Reports
  • Provide CSV expertise and risk analysis
  • Perform CSV GAP Analysis and develop the corresponding Remediation plans
  • Coordinate that software systems are implemented in conformance with CSV regulatory requirements and are in line with GAMP 5 standards
  • Supply technical guidance on global and local CSV policies and procedures

Profile

  • Experience in Validation Engineering in FDA regulated Pharmaceutical or medical devices environment with concentration in Computer System Validation (CSV)
  • Experience with the design of Validation documents like Validation plan, IQ/OQ/PQ Protocols, Test cases and Traceability Matrix, Summary reports.
  • Knowledge of FDA 21 CFR Part 11, 50, 58, 210, 211, 312, 314 and 820 and general principles of Software Validation Life Cycle
  • Knowledge of ISO 13485
  • Familiar with CSV compliant testing applications
  • Familiar with Infrastructure Validation is a plus
  • GxP advanced knowledge
  • GDPR basic Knowledge
  • Experience across the Microsoft Office Suite
  • Advanced skills in Microsoft Excel (pivot tables, macros, vlookups, complex formulae)
  • Advanced skills in Microsoft PowerPoint and Word
  • Experience of working in demanding and challenging environments
  • Experience of working to tight deadlines
  • Ideally some experience with large global transformation programs and the full project life cycle from a CSV perspective
  • Experience with CSV in an SAP S4 Hana environment
  • Highly organized and with an eye for detail
  • At least 5 years’ experience in a similar function
  • Strong verbal and written communication skills in English

Offer

  • 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

Interested?

Bezoek pauwelsconsulting.com voor meer informatie over de vacature Global CSV Compliance Officer of solliciteer online op de vacature Global CSV Compliance Officer.

Leuven

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54 days left to apply

Characteristics

Requirements

  • Master (University or Higher Education Long Type)

Offer

  • Permanent
  • Independent
  • Full-time
  • Company car

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