Computer System Validation(CSV) 3

2 days ago

Hyderabad, Telangana, India Alignity Solutions Full time ₹ 9,00,000 - ₹ 12,00,000 per year
Do you love a career where you Experience, Grow & Contribute at the same time, while earning at least 10% above the market? If so, we are excited to have bumped onto you.

Learn how we are redefining the meaning of work, and be a part of the team raved by Clients, Job-seekers and Employees.
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If you are a Computer System Validation(CSV) professional, looking for excitement, challenge and stability in your work, then you would be glad to come across this page.

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.

Check if you are up for maximizing your earning/growth potential, leveraging our Disruptive Talent Solution.

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.



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