UST is looking for an experienced CSV / CSA Lead (Computer System Validation / Computer Software Assurance) to lead validation and assurance activities for GxP-regulated computerized systems across laboratory, manufacturing, quality, and enterprise environments.

Experience 10-15+ Years

Domain Life Sciences / Pharma / Biotechnology / Medical Devices Location Global Delivery / Hybrid

Key Responsibilities

CSV / CSA Strategy & Governance

- Define and maintain CSV/CSA methodologies, procedures, templates, and governance frameworks.
- Drive adoption of risk-based Computer Software Assurance (CSA) approaches and industry best practices.
- Standardize validation processes across programs, sites, and business units.
- Support the development and maturity of Validation / CSA Centers of Excellence (CoE).

Validation Lifecycle Leadership

- Lead the end-to-end computerized system validation lifecycle.
- Develop and review Validation Plans, IQ, OQ, PQ, and Validation Summary Reports.
- Conduct risk assessments and gap analyses.
- Ensure requirements traceability across testing, approvals, defects, and deployment.

Regulatory Compliance & Inspection Readiness

- Ensure compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ Data Integrity principles.
- Partner with Quality Assurance teams to support regulatory inspections and audits.
- Support CAPA, deviations, remediation activities, and inspection responses.
- Act as a CSV/CSA subject matter expert during audits and regulatory inspections.

Data Integrity

- Serve as a Data Integrity SME for regulated computerized systems.
- Ensure effective implementation of audit trails, electronic signatures,



user access controls, traceability controls, and data lineage requirements.
- Assess and mitigate data integrity and compliance risks.

Leadership & Continuous Improvement

- Lead validation planning and execution across multiple projects and global teams.
- Collaborate closely with QA, IT, Manufacturing, Laboratory, Quality Systems, and Business stakeholders.
- Identify opportunities for validation automation, standardization, and process optimization.
- Mentor teams and provide guidance on CSA methodology and risk-based decision-making.
- Support digital transformation initiatives involving regulated systems.

Required Experience & Skills
- 10–15+ years of experience in Life Sciences and GxP-regulated environments.
- Proven experience leading CSV and CSA programs.
- Robust hands-on understanding of:
- Computer System Validation (CSV)
- Computer Software Assurance (CSA)
- GAMP 5
- FDA 21 CFR Part 11
- EU Annex 11
- ALCOA+ principles
- Data Integrity
- Risk Assessments
- Requirements Traceability
- CAPA & Deviation Management
- Experience supporting regulatory inspections and audits.
- Strong stakeholder management, communication, mentoring, and leadership capabilities.

Systems / Platforms Experience Experience validating one or more of the following:
- LIMS: LabWare, LabVantage, SampleManager
- MES / Manufacturing Systems
- QMS: Veeva QMS, MasterControl, TrackWise
- ERP Systems
- ELN
- CDS
- Laboratory and other GxP-regulated computerized systems

Validation Tools Exposure to validation and lifecycle management tools such as:
- ValGenesis
- Kneat
- HP ALM
- Veeva Validation Solutions
- Related validation/quality toolsets

📌 Consultant (Bengaluru)
🏢 UST
📍 Bengaluru