4 GxP Validation Test Lead Jobs in Princeton, NJ

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GxP Validation Test Lead

Xlysi

Princeton, NJ | Full Time

$97k-115k (estimate)

2 Months Ago

Kronos Test Lead

Diverse Lynx

Princeton, NJ | Full Time

$111k-130k (estimate)

Just Posted

Semiconductor Test Engineer with Security Clearance

SRI International

Princeton, NJ | Other

$111k-127k (estimate)

5 Days Ago

Validation/Test Lead

Diverse Lynx

Princeton, NJ | Full Time

$103k-117k (estimate)

1 Day Ago

GxP Validation Test Lead

Xlysi Princeton, NJ

$97k-115k (estimate)

Full Time 2 Months Ago

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Xlysi is Hiring a GxP Validation Test Lead Near Princeton, NJ

Computer System Validation and Quality Lead with work experience in GxP-regulated areas in the Life Science industry
Proven track record in delivering excellence, on-time delivery, and ensuring the quality of deliverables by implementing QA best practices, regulations, and GDP guidelines.
• Specialist in Pharma and Medical Device environment with expertise in Computer System Validation (CSV), Quality Assurance, and Process Guidance. Testing and Technical Documentation in Compliance with global regulations, industry standards, and best practices.
• Skilled at CSV of – Clinical Trial systems, Pharmacovigilance and R&D systems, Enterprise level Quality Systems, and various other custom-built and COTs products used across the LS industry.
• Experienced in SDLC compliance validation for GxP computerized systems and applications with regulatory requirements and controls associated with CFR 21 FDA Part 11, Annex 11 and EU GMP Annex 1
• Excellence in developing Quality Management Systems (QMS), including SOP, Working Practices, and Templates for Pharmaceutical companies with the guidance of Quality Teams.
• Participated in QualityRisk Assessment (Regulatory, Data Integrity, General Data Protection Regulation (GDPR) Assessment, and Cloud) and documentation as per GAMP 5 guidelines.
• Well-versed with FDA’s latest guideline, i.e., Computer System Assurance (CSA)
• Works in Validation Planning and Execution for CSV projects. Well-versed in authoring, reviewing, and approving validation documents such as Validation Plan/Report, Data migration Plan/Report, Technical Functional Risk Assessments, Validation/Qualification Protocols (IQ, OQ, UAT, and PQ), Traceability Matrix, Validation Summary reports, etc.
• Practices Data Integrity across GxP towers and computerized systems
• Performs Deviation Management, CAPA management, and Effectiveness Check Reports.
• Follows a risk-based approach in project execution.
• Works in Methodologies: Agile, Waterfall, V-Model