Saurabh Aswal

Computer System Validation (CSV) Engineer with 5+ years of experience in pharmaceutical and life sciences environments. Skilled in the complete CSV lifecycle, including URS, FRS, Risk Assessments, Validation Planning, IQ/OQ/PQ execution, Traceability Matrix preparation, Change Control, Deviation Investigation, CAPA management, and Periodic Reviews. Strong knowledge of FDA 21 CFR Part 11, GAMP 5, EU Annex 11, Data Integrity (ALCOA+), and Good Documentation Practices (GDP).

Experienced in working with Quality, IT, and Business teams to ensure GxP compliance, maintain validated systems, support audits, and drive continuous process improvements. Proven ability to deliver validation activities with a strong focus on quality, compliance, and regulatory requirements.

Officer Quality Assurance - CSV & Equipment Validation - Green Planet Industries LLC - Dubai

(2023-09)

• Led Computer System Validation (CSV) activities for GxP-regulated systems, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity requirements.
• Managed the complete validation lifecycle, including Validation Planning, URS, FRS, Risk Assessments, DQ/IQ/OQ/PQ execution, Traceability Matrix development, and Validation Report preparation.
• Conducted risk-based assessments to determine system criticality, validation scope, and compliance impact, enabling efficient and regulatory-compliant validation strategies.
• Collaborated with Quality Assurance, IT, QC, Manufacturing, R&D, and Business stakeholders to successfully implement, validate, and maintain computerized systems in a validated state.
• Supported regulatory inspections, client audits, and internal quality audits by providing validation documentation, compliance evidence, and timely remediation of observations.
• Managed Change Controls, Deviations, CAPAs, and Periodic Reviews to ensure continuous compliance and effective lifecycle management of validated systems.
• Performed system impact assessments, gap analyses, effort estimations, and regression testing activities for system enhancements, upgrades, and software releases.
• Supported Veeva Vault Complaints Module through issue investigation, workflow optimization, upgrade validation, IQ/OQ documentation, and product backlog management, contributing to improved system performance and user experience.
• Developed and reviewed validation deliverables while ensuring complete traceability between business requirements, testing activities, and validation outcomes.
• Performed continuous improvement initiatives by identifying compliance risks, strengthening validation processes, and promoting CSV best practices across cross-functional teams.
• Provided guidance and training to team members on CSV methodologies, regulatory expectations, GxP compliance, and industry best practices.

Officer Quality Assurance - Unichem Laboratory Privet Limited - Ghaziabad, India

(2022-03 - 2023-07)

• Executed CSV lifecycle activities: requirement analysis, validation planning, risk assessments, and protocol development (DQ/IQ/OQ/PQ).
• Prepared and reviewed CSV documentation ensuring compliance with GxP, FDA 21 CFR Part 11, GAMP 5.
• Supported validation of software applications, instruments, and manufacturing equipment.
• Collaborated with cross-functional teams to complete validation deliverables.
• Provided audit support by supplying validation evidence.
• Managed deviations, CAPAs, and change controls under QMS guidelines.
• Maintained CSV document repositories for audit readiness.
• Performed calibration and validation of pharmaceutical equipment as per GMP standards.

Executive Quality Assurance - Premas Biotech Privet Limited - Gurugram, India

(2020-10 - 2022-03)

• Led validation projects ensuring compliance with GxP, FDA 21 CFR Part 11, EU GMP, GAMP 5.
• Developed and executed VMP, URS, and DQ/IQ/OQ/PQ protocols.
• Performed risk assessments and coordinated cross-functional project teams.
• Supported audits by providing documentation and closing findings.
• Drove continuous improvement and mentored junior engineers.
• Performed calibration and validation of pharmaceutical equipment as per GMP standards.
• Developed and executed IQ/OQ/PQ protocols and calibration schedules.
• Conducted risk assessments and created calibration documentation.

Master of Business Administration - Healthcare Management - D.Y. Patil University (2025)

Master of Science - Microbiology - Sri Dev Suman University (2020)

Bachelor of Science - Zoology, Botany, Chemistry - Hemavanti Nandan Bahuguna University (2018)