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We are an IT Solutions Integrator/Consulting Firm helping our clients hire the right professional for an exciting long term project. Here are a few details.
Title: Analyst/Consultant – Life Sciences Digital Quality (CSV)
Key Responsibilities:
Identify and manage regulatory risks to ensure compliance, governance, and controls.
Collaborate with cross -functional teams on application development and validation projects, including risk analysis and QA reviews.
Author validation strategies, protocols, and summary reports (end -to -end CSV experience required).
Partner with R&D, Engineering, IT, Manufacturing, and Quality Assurance teams for project execution and training.
Plan, manage, and execute installation, operational, and performance qualifications per cGMP standards.
Review and approve validation lifecycle documentation.
Provide Quality review and assessments for change requests impacting processes, IT infrastructure, and systems.
Requirements:
2–6 years of experience in Computer System Validation (CSV).
Hands -on experience in validation within Agile SDLC.
Proficiency with tools such as JIRA, HP ALM, Qtest, SAP Solution Manager, ServiceNow, Valgenesis, and Veeva.
Experience with processes like Change Management, Periodic Reviews, and CAPA/Deviation Management.
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