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.
Responsibilities: - 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.
Requirements: - Bachelor's Degree (Computer Science / Software Engineering).
- Advanced - 5-10 years.
- Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation.
- Strong written and oral communication skills.
- Strong organizational and time management skills.
