Ayush Gupta

To Obtain a challenging and rewarding role as a CSV Project Engineer Where I can utilize my skills and experience to ensure the successful validation of computerized system, software, and equipment in the pharmaceutical industry. I aim to leverage my expertise in CSV, quality assurance, and project management to drive compliance, efficiency, and innovation, while advancing my career and contributing to the success of the organization.

Project Engineer - Arizona Automation & Technologies - Ahmedabad, Gujarat 380051

Computer System Validation (CSV) ensures that IT systems in regulated industries (like pharmaceuticals) meet intended use and comply with regulatory standards. It involves rigorous testing, documentation, and validation processes to confirm that systems reliably produce accurate and consistent results, ensuring data integrity, product quality, and patient safety. Worked on CSV (Computer System Validation) projects for pharmaceutical companies such as Panacea Biotec Baddi, Zydus, Getwell Pharma, Indoco and others.

ITQA Executive - Panacea Biotec Ltd. - Baddi

(2026-02)

• Computer System Validation (CSV) documentation, execution and compilation.
• 21 CFR Part 11 upgradation activities and compliance monitoring.
• Preparation, review and approval coordination of validation documents (URS, FS, IQ, OQ, PQ).
• QMS documents review (SOPs, Protocols, Reports, Change Control, Deviation, CAPA).
• Ensuring data integrity and regulatory compliance as per GxP guidelines.
• Coordination with cross-functional teams for validation activities.

ITQA Executive - Unichem Laboratories Limited - Kolhapur

• Preparation of CSV Documents (URS, GXP, VP, CS, FRS, FRA, IQ, OQ, PQ, RTM, VSR, SRC)
• Execution of CSV documentation
• Ensuring compliance with GAMP 5 and 21 CFR Part 11 requirements.

B-tech - Computer Science & Engineering - Gandhi Institute for Technology (2022 - 2026)

Intermediate - H.N.K inter College (2020 - 2022)

Matriculation - Sri Harkhen Kumar Jain Gyanshali (2020)