Responsibilities:

1. Contribute to project’s overall Computer System Validation deliverables.
2. Create and execute test scenarios; select the best testing methodologies, techniques and evaluation criteria for testing.
3. Draft, review and approve validation deliverables such as user requirements, technical design specifications, IQ/OQ/PQ scripts and reports, error logs, configuration document, traceability matrix and document 21 CFR Part 11 and EU Annex 11 compliance.
4. Help the leads in designing the test automation scripts and designing/configuring the test automation frameworks.
5. Understand the various testing activities: Unit, System, Component, User Acceptance, Performance, Integration and Regression.
6. Participate in user story mapping, sprint planning, estimation, and feature walk-throughs.
7. Experience in leading junior test analysts, assigning and tracking tasks provided to team members.
8. Manage end to end testing / validation lifecycle on applications likes - Solution Manager, JIRA, and HP ALM (desired).
9. Self - motivated, team-oriented individual with strong problem-solving abilities
10. Evaluate risks, assess closure requirements, and process change controls for computerized systems.
11. Define key test processes, best practices, KPIs, collateral.
12. Exposure to ETL or automation testing s good to have.

Qualifications:

1. Bachelor's/master’s degree in engineering,



Science, Medical or related field.
2. Hands-on experience in Computer System Validation of Applications and Infrastructure Qualification.
3. A minimum of 3.5 to 6 years of experience in computer systems validation and hands on experience within GxP (GCP/GMP regulated environment (FDA, EU, MHRA)).
4. Experience in managing and leading testing related activities.
5. Experience in creating test scenarios and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC or Agile phases as per the standard GxP protocol.
6. In-depth understanding of defect management processes.
7. Solid SQL skills for data validation and development of expected results.
8. Hands on Test Management Tool – JIRA and HP ALM.
9. Experience in defining risk-based strategies for validation of computerized systems and author review end-to-end CSV documentation in accordance with various test plans.
10. Understanding CSV and project related SOP’s and WI’s. Well versed in Good Documentation Practices.

Additional Skills:

1. Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint)
2. Exposure to ETL/DW/BI/Automation platform.
3. SQL skills for development of expected results and troubleshooting problems found during testing
4. Good Verbal and non-verbal communication skills

📌 Sr. Validation Testing Associate (Pune)
🏢 ZS
📍 Pune