CSV & Data Analytics Specialist

3 weeks ago

Bengaluru, India Infocus Technologies Full time

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

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