CSV Consultant
On behalf of a global client, RED is currently looking for multiple CSV Consultant to join a hybrid project.
Title: CSV Consultant
Start: ASAP
Duration: 12months +
Capacity: 8h a day, 5 days a week
Language: English
Location: 2 days onsite in Oss weekly
Skills:
At least 5-8 years of experience working in a Pharmaceutical/Biotechnology industry; experience working in a health authority regulated (eg GxP) environment.
Industry experience including computer system validation, System Life Cycle (SLC), software validation, and/or Quality Assurance functions.
High level of expertise and exposure with agency regulations, such as 21 CFR Part 11, Part 58, Part , Part from the US Food and Drug Administration.
High level of expertise in SLC methodology (eg, V-model, waterfall, agile, spiral) including change management.
Extensive experience providing oversight for adherence to enterprise SLC and procedures.
Experience in creation, execution, and reviewing a change control document.
Proficient skills dealing with and understanding typical laboratory facilities and equipment
If this is something you would be interested in, please apply with an updated CV/Resume, which includes your specific experience on the above and I will be in touch to discuss this opportunity in more detail ASAP.
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