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ClifyX

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3.8

based on 23 Reviews

1,261 ClifyX Jobs

IT Validation Lead

Clifyx Technology.

3.8

based on 23 Reviews

8-13 years

Bangalore / Bengaluru

1 vacancy

IT Validation Lead

ClifyX

posted 3+ weeks ago

Job Role Insights

Fixed timing

Key skills for the job

Pharmacy DevOps Project Management Gaming Compliance Medical Devices

+ 2 more

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 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 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 unit
Prepare management reports regarding compliance operations and progress