Job Title

Hiring for aservice-basedcompany which providestechnology-enabled solutions ,Designation- Validation Systems Analyst Experience Required: 3.5 Years -11Years Location- Pune/GurugramResponsibilities: Contribute to project’s overall Computer System Validation deliverables. Create and execute test scenarios; select the best testing methodologies, techniques and evaluation criteria for testing. 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. Build automation scripts and help the leads in the designing/configuring the test automation frameworks. Understand the various testing activities: Unit, System, Component, User Acceptance, Performance, Integration and Regression. Participate in user story mapping, sprint planning, estimation, and feature walk-throughs. Experience in leading junior test analysts, assigning and tracking tasks provided to team members. Manage end to end testing / validation lifecycle on applications likes - Solution Manager, JIRA, and HP ALM (desired). Self - motivated, team-oriented individual with strong problem-solving abilities Evaluate risks, assess closure requirements, and process change controls for computerized systems. Define key test processes, best practices, KPIs, collateral. Well verse with ETL or automation testing. Qualifications: Bachelor's/master’s degree in engineering, Science, Medical or related field. Hands-on experience in Computer System Validation of Applications and Infrastructure Qualification. A minimum of 3.5-6 years of experience in computer systems validation and hands on experience within GxP (GCP/GMP regulated environment (FDA, EU, MHRA)). Experience in managing and leading testing related activities. 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. In-depth understanding of defect management processes. Strong SQL skills for data validation and development of expected results. Hands on Test Management Tool – JIRA and HP ALM. 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. Understanding CSV and project related SOP’s and WI’s. Well versed in Good Documentation Practices.