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DL

IT CSV Validation Lead

Diverse Lynx India
🇮🇳 India
On-site
Staff / Principal
1 week ago
  • Agile
  • Devops
  • GxP
  • Jira
  • Confluence
  • Azure DevOps
  • Jenkins
  • Bitbucket
  • GitHub
  • Ansible
  • CI/CD
1 week ago
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IT 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 progress
Project Location 1
Pan India
Relevant Experience
7-8 years
Mandatory skills
• 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 progress
Desired skills
• 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 progress
Domain (Industry)
Life Science
Total Experience (Ex. 5-7 Years)
7 – 14 years
WFO / WFH / Hybrid
Hybrid
Please enter shift timings
9 AM to 6 PM
Shift Timings
General

Location- PAN India
Yrs of Exp-8Yrs

IT CSV Validation Lead · Diverse Lynx India

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