Computer System Validation (CSV), Compliance And IT QA Tester

• Skills – Mandatory- ITQA, software lifecycle development cycle, Experience in GXP Domain
• Skills - Primary Knowledge and Experience in GXP Compliance
• Skills - Good to have- Experience in Lifesciences/Pharmaceutical Industry.
• Qualification - Graduation
• Total Experience- 5+ years
• Relevant Experience - 5+ years
• Work Location TVM/Kochi
• Expected Date of Onboarding - Immediate
• Job Purpose

The objective of this scope of work is to engage who can cater Personnel with expertise in both ITQA (Testing software) along with IT CSV Discipline and GXP compliance. Personnel with work experience in GxP Domain is a must. These individuals will be responsible for conducting testing within the system to ensure compliance and functionality.

• / Duties and Responsibilities
• 1) Carries out functions of ITQA as directed by customer.
• 2) Author and Review of key computer system Validation Life Cycle (VLC) deliverables.
• 3) Author and Review OQ test scripts for various computer systems.
• 4) Identify Risk and test strategy for Change Management of projects.
• 5) Execute test scripts and perform identified defect management.
• 6) Prepare Traceability matrix and summary reports and ensure Compliance.
• 7) Operate effectively and with minimal supervision within a team/independent.
• 8) Adhere to ISMS policies and procedures.
• Job Specification / Skills and Competencies
• 1) Demonstrated knowledge and experience in GXP compliance.
• 2) Prior In-depth Experience in Lifesciences/Pharmaceutical Industry.
• 3) Proficiency in software lifecycle development cycle and ITQA.
• 4) Ability to understand and interpret regulatory requirements related to GXP compliance.
• 5) Working Knowledge of quality systems and regulatory requirements (21 CFR Part 11)
• 6) Author and Review:

• Review User Requirements/Functional Requirements and Software against Requirements.
• Ensure compliance with regulatory requirements and internal standards.
• Author and Review IQ, OQ and Contribute towards PQ.

7) Testing:

• Conduct Risk based and Regression testing within the system to verify functionality and compliance.
• Expertise in testing UI, API, and Backend Solutions.
• Develop and execute test scripts. Proficiency in automation tools like Playwright/Selenium.
• Expertise in TypeScript, JavaScript, Java.
• Document and report test results.