CSV & Data Analytics Specialist
- Infocus Technologies
- 2 - 7 years
- Bengaluru
- 5 months ago
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Job Description
Job Title: Computer System Validation (CSV) Specialist with Data Analytics Experience
Location:Bangalore, India
Role Overview:
We are looking for a Computer System Validation (CSV) Specialist with strong experience in validating GxP-regulated systems, along with working knowledge of data analysis. This is a hybrid role suited for someone who understands both compliance and data-driven decision making in regulated environments (e.g., pharma, biotech, healthcare).
Key Responsibilities:
- Perform and document Computer System Validation (CSV) activities as per GAMP 5, FDA 21 CFR Part 11, and other regulatory standards.
- Prepare and review validation documentation: URS, IQ, OQ, PQ, risk assessments, traceability matrices.
- Coordinate with QA, IT, and business teams to ensure systems are validated and compliant.
- Conduct periodic reviews, deviation handling, and change control processes.
- Use data analysis tools (Excel, SQL, Python, Power BI, etc.) to review and analyze system data, support audits or performance metrics.
- Contribute to audit readiness and support internal/external regulatory inspections.
- Maintain validation status of systems across the lifecycle (implementation, upgrade, retirement).
Required Skills:
- 2+ years of hands-on experience in CSV in a regulated environment (pharma, biotech, medical devices)
- Strong knowledge of GxP, GAMP 5, FDA 21 CFR Part 11, Annex 11
- Experience preparing and reviewing validation documents
- Familiarity with data analysis tools: Excel, SQL, Python, or BI tools
- Understanding of risk-based validation and documentation best practices
- Good communication and collaboration skills
Job Classification
Industry: IT Services & ConsultingFunctional Area / Department: IT & Information SecurityRole Category: IT & Information Security - OtherRole: IT & Information Security - OtherEmployement Type: Full timeContact Details:
Company: Infocus TechnologiesLocation(s): Bengaluru
Keyskills: Data Analytics Computer System Validation Csv Data Analysis
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Infocus Technologies
Company Profile Infocus Technologies Pvt Ltd., started its journey in 2007 as a Business Consulting, Information Technology and Service Company. We are primarily focused on SAP Consulting, Implementation and Support services. The company is promoted by a group of senior IT and Management professio...
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