Job Title: Validation Lead
Location: Raritan, NJ(Hybrid)
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.
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