Sakshi Shelke

Msc. Microbiology graduate with hands on experience in clinical trial supply industry. Skilled in GMP, GDP, SOP compliance, documentation control, SAP operations, CAPA, deviation handling, quality inspections and clinical trial material management.

Experienced in ensuring regulatory compliance, maintaining product quality, and supporting quality systems throughout the product lifecycle. Detail-oriented, analytical, and committed to maintaining the highest quality standards in pharmaceutical manufacturing.

Quality Assurance - Seveillar clinical supplies service Pvt Ltd.

(2025-12)

Worked closely with operations and project teams to ensure quality compliance throughout packaging activities.

• Ensured product blinding integrity throughout the clinical trial life cycle.
• Reviewed packaging documentation, label printing records, and inspection checklists for compliance with GMP and SOP requirements.
• Performed SAP transactions supporting Quality Assurance and operations activities.
• Verified packaging materials and labels before execution and dispatch.
• Maintained accurate batch documentation and ensured compliance with GDP.
• Supported CAPA implementation, deviation investigation, and quality documentation.
• Performed quality checks to ensure compliance with study protocols and regulatory requirements.
• Coordinated inventory reconciliation and traceability of clinical trial materials.
• Assisted in maintaining documentation readiness for internal and external audits.

Industrial Training - ITC food division - Ranjangoan

(2024-06 - 2024-06)

Gained practical exposure to GMP and safety standards.

Research Intern - Agharkar research institute - Pune

(2024-07 - 2024-07)

Learned microbiological laboratory practices, aseptic techniques, and research documentation.

M.sc. - Microbiology - Dr. D.Y. Patil ACS college Pimpri (2025)

B.sc. - Microbiology - Dr. D.Y. Patil ACS college Pimpri (2023)