Job Description
The
CSV Specialist Level 4 provides team leadership and training to assess new and
changing computer systems to ensure compliance with company policies,
procedures and industry guidance.
The CSV Specialist Level 4 will risk assess systems, review change requests and
test scripts, draft protocols and initiate and review GMP documentation
revisions.
Specialist will be involved as the QA CSV representative during small and
large-scale projects.
Perform
all aspects of QMS process' – Change Control, Deviations, CAPAs
• Execute all responsibilities as CSV project lead for complex projects
• Oversee all CSV lifecycle activities
• Schedule qualification activities and personnel to meet business,
manufacturing, engineering and quality objectives
• Mentor junior specialists
• Revise and maintain CSV SOPs
• Assess departments standing in the business and regulatory aspects
• Function as CSV SME in Inspections and Audits
• Perform other duties as assigned.