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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