Validation Specialist

Cognizant; Hyderabad; Hybrid; INR 1,200,000 - 2,400,000; Full time

Job summary

Cognizant is seeking a LIMS Testing Specialist Senior QA Analyst focused on Computer System Validation in Hyderabad. The role requires designing and executing LIMS tests, validating configurations, and producing CSV artifacts to ensure regulatory compliance and audit readiness.

You will manage test plans and defects using ALM tools and collaborate with QA, IT, and Lab Operations to drive validated LIMS go-live readiness. 6–12 years in pharma/biotech is preferred.

Qualifications

• 6–12 years in Pharmaceutical/Biotech or Life Sciences manufacturing.
• Experience designing and executing LIMS tests and CSV deliverables.
• Knowledge of GAMP 5, 21 CFR Part 11 and EU Annex 11 data integrity.
• Ability to manage test plans and defects using ALM tools.

Responsibilities

• Design and execute functional, integration, regression, and UAT tests for LIMS modules.
• Validate LIMS configurations, workflows, calculations, and result approvals.
• Author CSV documentation: URS, FRS, IQ, OQ, PQ protocols.
• Maintain traceability matrices for audits and support regulatory inspections.
• Collaborate with QA, IT, and Lab Operations to achieve go-live readiness.

Skills

LIMS testing

Test design & execution

UAT testing

CSV protocols

Regulatory compliance

Test plan management

Audit readiness

Tools

HPE ALM

Jira Xray

Job description

LIMS Testing Specialist Senior QA Analyst Computer System Validation

Job Description:

• Experience 6 to 12 years in Pharmaceutical Biotech or Life Sciences Manufacturing
• Design and execute functional integration regression interface and UAT test cases for LIMS modules
• Validate LIMS configurations workflows calculations and result approval hierarchies
• Author and execute CSV deliverables including URS FRS IQ OQ PQ protocols
• Ensure compliance with GAMP 5 21 CFR Part 11 and EU Annex 11 data integrity requirements
• Manage test plans test cases and defects using ALM tools like HPE ALM or Jira Xray
• Maintain requirements to test case traceability matrices for audit readiness
• Support risk assessments change control and regulatory inspections for LIMS systems
• Collaborate with QA IT and Lab Operations to drive validated LIMS go live readiness

Location- Hyderabad

Notice Period- 0-30 Days (Officially)