Senior Validation Consultant Impetus Career Consultants
Impetus Career Consultants
Office Location
Full Time
Experience: 4 - 4 years required
Pay:
Salary Information not included
Type: Full Time
Location: Maharashtra
Skills: Client Engagement, Unit Testing, System Testing, User Acceptance Testing, performance testing, Integration Testing, Regression Testing, Sprint Planning, risk assessment, Defect Management, SQL, JIRA, HP ALM, ETL, Validated systems testing expertise, End to end test management expertise, automation scripts, test automation frameworks, testing methodologies, User Story Mapping, Feature walkthroughs, Change Controls, Good Documentation Practices
About Impetus Career Consultants
Job Description
Hiring Across all the levels . Location-Pune Preferred/ Gurgaon Mandatory Skillset Validated systems testing expertise Validated Systems Testing and end to end test management expertise + Strong client engagement Validated Systems Testing and end to end test management expertise Responsibilities: Contribute to projects 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/masters degree in engineering, Science, Medical or related field. Hands-on experience in Computer System Validation of Applications and Infrastructure Qualification. A minimum of 3.5-11 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 SOPs and WIs. Well versed in Good Documentation Practices.,