Experience:
15+ years

Education:
Bachelor's degree in Engineering Skill

Requirements:
• Strong expertise in Computer System Validation (CSV), Commissioning, Qualification and Validation (CQV), and Computer Software Assurance (CSA)
• Extensive experience in Quality Management Systems (QMS) implementation and compliance governance
• Experience in validation and qualification of AI/ML/DL products and SaaS platforms
• Solid knowledge of GxP, FDA regulations, Data Integrity, Pharmacovigilance, Clinical Trials, and MedicalDevices compliance
• Experience in supplier qualification, audit management, and remediation activities
• Hands-on expertise in equipment validation, infrastructure qualification, and cloud platform validation including AWS
• Knowledge of manufacturing systems, clinical data management, and regulatory reporting systems
• Experience in Quality Risk Management, SOP development, validation lifecycle documentation, and audit readiness
• Strong leadership capabilities in managing QA, Testing, Validation, and Compliance teams
• Experience in Agile project execution and quality governance frameworks

Responsibilities:
• Lead Quality Assurance, Compliance, Validation,



and Testing functions across products and solutions
• Establish and maintain Quality Management Systems (QMS) and compliance frameworks
• Define and implement CSV, CSA, CQV, and validation strategies for software, infrastructure, and regulated systems
• Oversee supplier qualification programs, vendor audits, and supplier management processes
• Support internal and external regulatory audits and remediation activities
• Develop QA policies, SOPs, validation guidelines, and quality documentation standards
• Lead qualification and validation activities for AI/ML 3A/F/08-01 Page 2 of 2

Job Description
SOP No 3A/SOP/005-05 Format No 3A/F/08-01 platforms, pharmacovigilance systems, medical devices, and clinical applications
• Establish quality culture and compliance-driven product development lifecycle practices
• Manage training plans, competency programs, and performance evaluation frameworks for QA and Validation teams
• Collaborate with leadership teams to ensure regulatory compliance and product quality objectives
• Drive continuous improvement initiatives, risk mitigation, and inspection readiness programs

📌 Lead Validation Engineer (Chennai)
🏢 3Analytics
📍 Chennai