KEY RESPONSIBILITIES

GxP Compliance & Advisory

▪ Provide GxP compliance and validation expertise across IT infrastructure, applications and cloud platforms (AWS, GCP, Azure).

▪ Apply FDA 21 CFR Part 11, EU Annex 11, GAMP 5 and ALCOA+ data integrity principles to up-to-date IT environments.

▪ Advise on regulatory implications of cloud services, IaC, CI/CD, automated testing and vendor-managed SaaS platforms.

Validation & Documentation

▪ Support the full CSV lifecycle — validation planning, requirements, risk assessment, IQ/OQ/PQ protocols, traceability,

deviations and summary reports.

▪ Apply Computer Software Assurance (CSA) principles to focus test effort on patient safety, product quality and data integrity

risk.

▪ Develop and review SOPs, work instructions, qualification protocols and compliance procedures; keep documentation audit

ready.

▪ Review supplier documentation and support qualification of GxP-relevant technology providers.

Assessment, Audit & Risk

▪ Assess systems and processes against applicable GxP requirements and identify gaps with prioritized,



practical remediation.

▪ Support audit readiness, client audits and regulatory inspections — evidence collection, response preparation and remediation

tracking.

▪ Support risk assessments, system classification, change control, revalidation determination, periodic review and CAPA closure.

Cross-Functional Delivery

▪ Work with security, infrastructure, application, DevOps and QA teams to implement appropriate technical and procedural

controls.

▪ Translate regulatory requirements into implementable controls — access control, audit trail, e-signature, backup/restore,

retention and segregation of duties.

▪ Provide training and enablement to client and Cywarden delivery teams on GxP expectations in technology environments.

REQUIRED SKILLS & EXPERIENCE

▪ Strong GxP regulatory experience across GMP, GLP and/or GCP as applicable.

▪ Demonstrated Computer System Validation experience across the fu

📌 GxP Subject Matter Expert (India)
🏢 Cywarden Global Services
📍 India