Responsibilities

Validation Lifecycle Leadership

- Author, review, and execute validation lifecycle documentation (VP, URS, FS, DS, IQ/OQ/PQ, Summary Reports)

- Develop and maintain Requirements Traceability Matrices (RTM) and Risk Assessments

- Lead validation activities for clinical, manufacturing, laboratory, and quality systems

Compliance & Quality Assurance

- Ensure strict adherence to FDA 21 CFR Part 11, EU Annex 11, GxP, and GAMP 5 principles

- Apply risk-based validation approaches per GAMP 5 categorization

- Perform gap assessments and develop remediation plans for legacy systems

Audit & Regulatory Support

- Support client audits (internal, vendor, regulatory inspections)

- Prepare validation evidence packages for regulatory submissions (FDA, EMA, MHRA)

- Respond to FDA 483 observations and CAPA implementations related to CSV

Collaboration & Knowledge Sharing

- Collaborate across time zones with global project teams and client stakeholders

- Mentor junior validation engineers on CSV best practices

- Contribute to Infiligences validation methodology and knowledge base

What You Bring

Required Qualifications

- Bachelors degree in Engineering, Life Sciences, Computer Science, or related field

- 7+ years of hands-on CSV experience in life sciences/pharmaceutical environments

- Deep expertise in validation lifecycle (V-Model, Agile Validation)





- Solid working knowledge of FDA 21 CFR Part 11, EU GxP, GAMP 5 (v5 categories), and Annex 11

- Experience validating systems such as: LIMS, ERP (SAP, Oracle), MES, SCADA, QMS, EDC, CTMS, or EHR/EMR platforms

- Proficiency in creating validation documentation per global standards

Preferred Qualifications

- Experience with CSV for cloud-based systems (AWS, Azure, Veeva, Salesforce)

- Familiarity with data integrity (ALCOA+) principles

- Knowledge of electronic signatures and audit trail requirements

- Exposure to automated testing tools for validation (Selenium, TestComplete)

- Prior experience supporting FDA/EMA/MHRA inspections

- Certifications: ASQ (CSQE, CQE), RAPS, or ISPE GAMP certification

Essential Skills

- Excellent technical writing and documentation skills

- Strong analytical and problem-solving abilities

- Detail-oriented with exceptional organizational skills

- Effective communication with technical and non-technical stakeholders

- Ability to work independently and manage multiple priorities

- Flexibility for occasional overlap with US/Canada time zones

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Validation and Verification Specialist (Chennai)
🏢 Infiligence
📍 Chennai