CSV Consultant

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 210, Part 211 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.