CSV Compliance Officer
As a Global CSV Compliance officer, you will be globally responsible for all CSV related activities. You will be the link between our IT and QA team.
What is your mission?
- You improve computer system compliance within GC Globally.
- You ensure documentation and practices meet quality standards, applicable regulatory compliance and IS guidelines/policies.
- you review user requirements, functional design specification, technical design specifications for clarity, Good documentation practices.
- You perform Validation and Qualification of GXP/Non GXP systems and infrastructure
- You write and execute Computer System Validation (CSV) Protocols and Validation Summary Reports
- You provide CSV expertise and risk analysis
- You perform CSV GAP Analysis and develop the corresponding Remediation plans
- You coordinate and ensure that software systems are implemented in conformance with CSV regulatory requirements and are in line with GAMP 5 standards
- You supply technical guidance on global and local CSV policies and procedures
Who are you?
- 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, with advanced skills in Microsoft Excel
- Highly organized and with an eye for detail
- At least 3 years’ experience in a similar function
- Strong verbal and written communication skills in English
What do we offer you?
- A challenging job with potential for growth in an international and diverse company.
- A permanent contract with full time employment.
- Flexible hours.
- Competitive salary package including benefits (meal vouchers, hospitalization and group insurance.
- Stunning offices and a great company culture, based on respect and comradeship.
- An opportunity to contribute to a better, healthier world in collaboration with colleagues who are passionate about what they do.
Who are we?
GC Corporation was founded in 1921 in Japan and has developed itself into one of the most prominent companies in the development, production and distribution of a very wide range of dental products.
Since 1972 GC Europe NV is located at the Researchpark Haasrode in Leuven. GC Europe NV supports and leads our different sales offices and dealers. Our warehouse spreads our products to Europe and the Middle East. Next to this we produce some leading products for dental technicians.
When applying, be sure to upload your CV and motivational letter to your profile!