CSV & Data Analytics Specialist

Infocus Technologies

2 - 7 years

8 - 12 Lacs

bengaluru

Posted:1 week ago| Platform:

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Skills Required

data analytics computer system validation csv data analysis

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Title: Computer System Validation (CSV) Specialist with Data Analytics Experience

Location:

Role Overview:

Computer System Validation (CSV) Specialist

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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