Computer System Validation(CSV) 3 - 6 Yrs

Job Description

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Requirements

Title : Analyst / Consultant – Life Sciences Digital Quality (CSV)

About the Role :

Deloitte’s Life Sciences IT Quality practice helps life sciences companies address regulatory compliance, technology, operations, and automation challenges through integrated, process-driven, and automated solutions. As part of this team, you will be responsible for developing, executing, and maintaining IT Quality initiatives. You will collaborate with clients and engagement teams to establish documented evidence for regulatory compliance and submissions. This role requires expertise in Part 11 compliance, ERP systems, Digital Health, R&D systems, regulatory submission systems, and governance frameworks.

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.

Benefits

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Requirements

Computer System Validation (CSV), Agile SDLC validation, JIRA, HP ALM, Qtest, SAP Solution Manager, ServiceNow, Valgenesis, Veeva, Change Management, Periodic Reviews, CAPA / Deviation Management