Validation Lead

Mandatory - Computer System Validation, IT Compliance Management
Validating Clinical systems and/or clinical supplies and/or Safety and/or Manufacturing systems, CAPA Management, Periodic Review

Job Description / Key Responsibilities:
• Oversee the testing phase of projects, ensuring that software and systems meet quality standards and business requirements.
• Has working experience in any one or two of the following domains - Clinical Development and Supply Chain, Drug Discovery, Safety
• Manage testing strategies, coordinating team activities, and ensuring seamless communication between development and testing teams.
• Monitor and report on test progress, coverage, and quality metrics to stakeholders.
• Strong in Project Management tools like JIRA, qTest
• Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams
• Develop and implement test plansTest cases: Create detailed test planscases and strategies to ensure comprehensive coverage of all functional requirements.
• Execute tests: Perform manual tests to identify any issues or defects in the software.
• Document outcomes: Record and track test results, documenting any discrepancies or bugs.
• Analyze test results: Collaborate with development teams to analyze test outcomes and ensure issues are resolved
• Problem-solving: Ability to troubleshoot and resolve issues efficiently.
• Communication: Strong verbal and written communication skills to effectively report findings.
• Team collaboration: Ability to work well with cross-functional teams to ensure quality throughout the software development lifecycle.