The Computer System Validation (CSV) Lead will report to the Jabil Healthcare Sr. Manager of Computer System Validation and will be responsible for leading, conducting, coaching, or supervising Computer System Validation projects within the scope of the Jabil Quality Management System of various sizes and scopes, such as enterprise systems, SaaS, stand-alone applications, and Excel spreadsheets.
This position requires strong collaboration with Quality, Information Technology, and Business Owners. The CSV Lead will participate in supplier assessments and provide support during audits and inspections, such as internal audits, FDA, BSI, etc.
1) Coordinates with Business owners and SMEs, IT representatives, and Quality to assess, scope, plan, lead, and complete validations of GxP IT items to ensure compliance with medical device quality system regulations and standards, Jabil Healthcare QMS procedures, and ensure high quality:
a) Complete Computer System Validation assessments
b) Participate in requirements analysis and author requirements specifications
c) Author validation plans
d) Review and conduct requirements traceability to design specifications
e) Participate in supplier assessments
f) Author test plans
g) Supervise and lead test development, dry-running, execution, and post-execution review
h) Author validation summary reports
2) Review and approve Computer System Validation deliverables and activities.
3) Develop and deliver training in a variety of formats, related to regulatory compliance, quality systems, and validation practices.
4) Participate in IT change control as a validation representative.
5) Mentor and coach Computer System Validation personnel and participants. 6) Participate in and support audits and inspections, such as internal audits, FDA, and BSI.
1) Strong leadership skills
2) Strong project-management skills
3) Strong regulatory and standards knowledge, such as 21 CFR 820, 21 CFR 11, and ISO 13485
4) Strong computer-science\technical knowledge
5) Strong validation testing knowledge
6) Strong problem-solving skills
7) Strong coaching\mentoring skills
8) Thorough knowledge and understanding of good documentation practices and GxP compliance requirements
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