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 modern 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 full lifecycle in regulated IT environments.

▪ Working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5 and data integrity / ALCOA principles.

▪ Experience authoring and reviewing validation documentation, SOPs, protocols and risk assessments to an audit-ready standard.

▪ Experience supporting audits, inspections and remediation, including evidence collection and response preparation.

Cywarden, Inc. · GxP Subject Matter Expert (SME) · Page 1 of 2

▪ Strong understanding of change control, quality risk management, deviation/CAPA and periodic review; able to work directly with technical teams.

PREFERRED, CERTIFICATIONS & EDUCATION

Preferred: Pharmaceutical, biotech, medical device or CRO/CDMO experience · validation of cloud-hosted and SaaS systems · CSA and risk-based testing · Veeva, LIMS, MES, SAP, EDMS or TrackWise · ISO 27001 / NIST / HIPAA / GDPR exposure · Agile in validated environments.

Certifications: ISPE GAMP 5 training · ASQ CQA or CSQE · RAC · ISO Lead Auditor (9001 / 13485 / 27001) · a foundational cloud certification is a plus. Hands-on capability takes precedence over credentials.

Education: Bachelor's degree in Life Sciences, Pharmacy, Engineering, Computer Science or related discipline, or equivalent qualified experience in regulated environments.

SUCCESS MEASURES — FIRST 30 / 60 / 90 DAYS

30 days

Review the client validation framework, SOP landscape, system inventory and GxP classification; deliver an initial compliance gap and risk summary.

60 days

Deliver the first compliance workstream — gap assessment, validation package, SOP set or audit readiness review — to quality acceptance.

90 days

Achieve audit-ready outcomes: remediated documentation gaps, completed validation packages, an agreed CAPA plan and a control model engineering can sustain.

Pay: ₹800.00 - ₹1,200.00 per hour

Work Location: Remote

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