Job 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 10+ 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 clients 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 units Prepare management reports regarding compliance operations and progress \',

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