Renuka Shastri

About Renuka Shastri

As a Quality Control Specialist at ARKRAY Healthcare Pvt. Ltd, I am responsible for method development, method validation, routine release, and stability testing for in vitro diagnostics (IVD) products. I have successfully faced a WHO audit with zero observations, thanks to my collaboration with cross-functional teams to author and review regulatory documentation, such as SOPs, batch records, and test reports. I hold an M.Sc. in Biotechnology from Veer Narmad South Gujarat University, where I gained knowledge and skills in recombinant protein production, affinity chromatography, and next-generation sequencing. I apply these skills in developing, validating, and testing bioassays and ELISA, especially for monoclonal antibodies and other large molecules. I also manage all Out of Specifications (OOS) investigations, deviations, CAPAs, and change controls per GMP standards, ensuring quality and safety of the products. Additionally, I have completed several certifications in pharmacovigilance, genetics, and bioinformatics, demonstrating my commitment to continuous learning and professional development.

Experience

1. Quality Control Senior Executive

   ARKRAY, Inc.

   Apr 2024 — Present · Surat, IN

Education

• Veer Narmad South Gujarat University, Surat

  Bachelor of biotechnology

  2015 — 2018

• Veer Narmad South Gujarat University, Surat

  M.Sc Biotechnology

  2018 — 2020