Somya Shrivas

Dynamic R&D Executive with 1.5 Years of Proficiency in Manufacturing High-Quality Lateral Flow and managing all regulatory requirements in aspects of quality and approvals.

Professional Experience

R&D Executive, NULIFE CARE PVT. LTD

Noida, Uttar Pradesh, 201301

• Preparation/Formulation
• Managements of GNPs Production and Conjugation Processes
• R&D & QC Testing
• Performed change control
• Prepare and Review Standard Operating Procedures (SOPs)
• Performing Stability testing
• Change Control (CCF)
• Handling Post Market Complaints
• Handling Internal Audits and its follow up Findings
• Manage all Regulatory work based on Quality control
• Maintained Internal Calibration
• Performed Risk Assessment
• Worked on Design & Developments
• Maintaining daily logs and other documents
• Coating of various sheets using ISO-Flow Bio-Dot Machine

CDSCO Audit (November, 2023)

Successfully handled CDSCO audit for manufacturing license of Class-C product

AKUMS Audit (December, 2023)

Successfully handled external audit conducted by Akums Drugs & Pharmaceuticals for manufacturing license of Class-B IVD Rapid Products

Zenith Audit (May, 2024)

Zenith Quality International Assessor for recertification of the manufacturing license of the plant

Defense Research & Development Organization (DRDO)

January 2023 – June 2023, Delhi

Project Title: “Comparative Evaluation of Angiogenesis”

Banaras Hindu University (BHU)

July 2022 – September 2023, Banaras

Project Title: “Establishment of Artemisia annual under in vitro condition”

Skills

• Preparation/Formulation
• R&D & QC Testing
• Change Control
• Stability Testing
• Regulatory Work
• Internal Audits
• Quality Control
• Risk Assessment
• Product Design & Development
• Manufacturing License Audits

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Cover Letter:

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