CSV Validation Lead

Description:

The candidate is expected to demonstrate excellent core competence and experience in delivery of IT CSV projects following Agile or DevOps methodology. The successful candidate shall possess:

• Overall experience of 8+ years
• In depth understanding of IT CSV, Agile and DevOps methodologies
• Deep understanding of pharmaceutical or medical devices value chain
• Open to other industries (Finance, gaming, etc.) with strong DevOps skillet and knowledge
• Ability to handle conversations with senior business and technology leaders from client teams

MAJOR ACCOUNTABILITIES

• In-depth knowledge of GxP, GAMP 5, 21 CFR Part 820, 21 CFR Part 11,
• Define IT system development processes (build, test, deploy, monitor) following Agile and DevOps ways of working and ensure followed compliance in each release /Iteration
• Working experience on Agile/JIRA, Confluence, ALM and other Azure DevOps tools (e.g. Jenkins, Bitbucket, GitHub, Ansible, etc.)
• Knowledge on automation framework for the project integrate with CI/CD pipeline.
• Author major project validation deliverables as per client’s standard operating procedures
• Review and approve system lifecycle deliverables generated by project team
• Guide project teams on applicable validation, security and project management deliverables
• Advise project team on implementation of compliance and security control requirements at the appropriate stages of system development
• Contribute to internal and external audits, assessments or inspections
• Escalate critical compliance findings, risks or issues into appropriate client unit
• Prepare management reports regarding compliance operations and progressRole & responsibilities

Preferred candidate profile