Aesha Bhavsar

Quality Assurance professional with 2+ years of experience in pharmaceutical and healthtech industries. Specialist in Computer System Validation (CSV) with a proven track record of delivering full validation lifecycle documentation — from URS through OQ/PQ — with zero critical deviations at go-live across multiple client engagements. Skilled in LIMS implementation, Electronic Lab Notebook (ELN) standardisation, and regulatory compliance under 21 CFR Part 11, EU Annex 11, and GAMP 5.

Proficient in leveraging modern AI tools including ChatGPT and Claude to accelerate documentation drafting, gap analysis, and SOP development — reducing turnaround time by up to 30%. Known for audit-ready deliverables, meticulous data integrity practices, and cross-functional stakeholder collaboration.

CSV Executive - Anthem GxP Solutions - Ahmedabad, India

(2026-07)

Quality Assurance Executive — Computer System Validation - Webo Healthtech Pvt. Ltd. - Ahmedabad, India

(2025-09 - 2026-07)

• Independently managed the end-to-end CSV lifecycle for 3+ life sciences clients, preparing and executing URS, FRS, Validation Plans, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and Summary Reports — delivering all projects on schedule with zero critical deviations at go-live.
• Validated BABE (Bioavailability/Bioequivalence) study management software within a regulated life sciences environment, ensuring full data integrity and regulatory submission readiness under 21 CFR Part 11 and EU Annex 11.
• Ensured continuous compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11 across all validated systems throughout the full validation lifecycle.
• Leveraged AI tools (ChatGPT, Claude) to accelerate SOP drafting, gap analysis, and validation document generation — improving documentation turnaround time by approximately 25–30%.
• Maintained SOP management frameworks and quality documentation systems to support continuous audit readiness and inspection preparedness.
• Collaborated cross-functionally with IT, QA, and regulatory teams to interpret client requirements and translate them into compliant validation deliverables within agreed timelines.

Quality Control Associate - Baxter Pharmaceutical India Pvt. Ltd. - Ahmedabad, India

(2022-07 - 2023-08)

• Led successful LIMS (Labvantage) implementation for packaging material testing, overseeing data migration, system configuration, and end-user training across QC, Doccell, and Quality teams — enabling go-live within a 6-month timeline.
• Developed 15+ standardised worksheet templates within the Electronic Lab Notebook (ELN), improving documentation consistency and reducing manual transcription errors across QC workflows.
• Built LIMS calculation sheets from technology transfer documents, reducing manual calculation errors by standardising formulas and improving data traceability for routine QC testing.
• Collaborated with cross-functional stakeholders to gather system requirements, validate migrated data, and configure LIMS modules in alignment with GMP and data integrity (ALCOA+) standards.
• Maintained GMP-compliant laboratory documentation and ensured data integrity across all LIMS records in a regulated manufacturing environment.

Master of Science - Analytical Chemistry - Institute of Advanced Research, Gandhinagar, Gujarat (2022)

Bachelor of Science - Chemistry - Gujarat University, Ahmedabad, Gujarat (2020)