Computerized System Validation Specialist

7 dagen geleden


Tilburg, Noord-Brabant, Nederland Oxford Global Resources Voltijd
Job Title: Computerized System Validation Specialist

About the Role:

We are seeking a highly skilled Computerized System Validation Specialist to join our team at Oxford Global Resources. As a CSV Specialist, you will be responsible for executing and leading GxP CSV projects in accordance with cGMP, 21 CFR Part 11, GAMP5, and Annex 15. Your primary goal will be to ensure that GxP systems meet the manufactured use and required requirements.

Responsibilities:

- Execute and/or lead GxP CSV projects in accordance with cGMP, 21 CFR Part 11, GAMP5, and Annex 15
- Ensure GxP systems meet the manufactured use and required requirements
- Monitor current industry practices and company policies and procedures
- Maintain knowledge of cGMP automation/computer systems validation within an EMA/FDA regulated environment

Requirements:

- Bachelor's or university degree in one of the target areas for the position (e.g. IT, Science or related field)
- Ability to thrive in a matrix organization, managing the interface between functional organization and project organization
- Excellent written and practical communication skills
- Good handling in time-sensitive and safe situations with proper risk assessment
- Ability to learn and work according to the latest industry standards and designated computer validation practices

What We Offer:

- Year contract through Oxford Global Resources
- Salary indication €4500 - €5500 gross per month based on experience
- 40 hours per week in day shift

Important Note:

Visa sponsorship is not possible for this position. Please do not apply if you do not have a working permit to live and work in the Netherlands.

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