Computer System Validation (CSV),GxP , GAMP, Agile-Immediate or 15 day

Kairos Technologies Inc.; Hyderabad, Chennai; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Kairos Technologies Inc. in Hyderabad, India, seeks a Validation Specialist to support quality and CSV activities across GxP systems. Primary language is English; strong verbal and written communication required.

You will work with manufacturing applications (SAP/ERP) and validation deliverables, review test scripts, create and maintain documentation, and collaborate with dispersed teams using Jira, Xray, and qTest. Familiarity with QA methodologies and traceability matrices is essential.

Qualifications

• CSV and Quality knowledge across SDLC for GxP systems.
• Experience with validation deliverables review (test scripts, etc.).
• Knowledge of GxP compliance and FDA/global regulations.
• Experience with system validation documentation (Validation Plans, Test Protocols, Test Summaries, Compliance/Validation Reports).
• Primary language English; strong verbal and written communication.

Responsibilities

• Write and execute documentation for all validation deliverables (Requirements, Compliance/validation Plans, Test Protocols, Test Summary reports).
• Review system test and UAT scripts, Traceability matrix and Design Specs; ensure QA methodologies in testing.
• Coordinate with dispersed/remote teams and escalate as needed to TQ manager.
• Design, review and approve Test Plans, systems and UAT test scripts and Test procedures.
• Review automated test scripts and maintain documentation quality.

Skills

CSV and Quality knowledge

GxP compliance

FDA/Global regulations

Validation deliverables review

Test scripts review

Communication skills

Collaborative teamwork

Tools

Jira

Xray

qTest

SAP ERP

Job description

Must have:

• CSV and Quality knowledge with ability to support validation activities across the SDLC for GxP systems.
• Experience with Manufacturing Applications - , SAP /ERP, Supply Chain management applications
• Knowledge of GxP compliance and FDA/Global regulations.
• Experience with validation deliverables review, including testing artifacts (e.g., test scripts).
• Primary Language required: English. Strong verbal and written communication skills.
• Knowledge of Agile Tools (e.g., Jira, Xray, qTest, etc.).
• Ability to build collaborative partnerships, work as a team player, including timely escalations to TQ manager.
• Ability to work with dispersed/remote teams and support several systems simultaneously.
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
• Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
• Ability to Review Automated Test script Strong verbal and written communication skills.