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

- Robust 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

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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