Responsibilities of the Global CSV Compliance Officer
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 of the Global CSV Compliance Officer
- 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 for the Global CSV Compliance Officer
- 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