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Profile Details

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USD 100 /hr

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Hire Dr. P. S. C.

India

USD 100 /hr

Subject Matter Expert (WHO-PQ, Medical Devices, Biologics, QA/QC, Accreditation, LIMS, QMS etc.

Profile Summary

Served as WHO-PQ coordinator for Support Cell for WHO Pre-Qualification Programme for In-vitro Diagnostics. 
Served as Expert panel member of Biotechnology Industry Research Assistance Council, Department of Biotechnology (BIRAC - FIRST-HUB) committee, a Facilitation Cell for the Start-ups/ innovators and for those who want to take up R&D in pharma and devices.
Core strength areas are QC & QA of In-vitro Diagnostics, Biologics, Development of Reference standards, application of relevant Data standards, Biobanking/Biorepository, Laboratory Information Management Systems (LIMS), Quality Management Systems (QMS) ISO - xxxxxxxxxxxx, xxxxxxxxxxxx, 17034 & 33, OHSAS & QHSE.
Planning and establishment towards Laboratory accreditation, Data integrity, Artificial Intelligence and IoT.
Quality evaluation & QA of IVDx of infectious disease marker's.
Project lead for Artificial Intelligence based in-house Laboratory Information Management System (LIMS) development at National Institute of Biologicals.
Research in Bioinformatics engaging Artificial Intelligence, Machine and Deep Learning methodologies.
Ability to multitask across platforms (Regulatory science, QMS, Informatics & Accreditation services). Well experienced in QC/QA of Biologics (Biotherapeutics - mAbs, enzymes, Immunodiagnostics - Infectious disease marker testing) in a well regulated, fast paced environment for Biologics.

Subject Matter Expertise

Services

Writing
Research
Consulting
Data & AI
Product Development

Writing Technical Writing

Research Market Research, Meta-Research, Feasibility Study, Fact Checking, Gray Literature Search, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis, Big Data Analytics, Data Insights

Product Development Stability/Shelf Life Testing, Product Validation, Prototyping

Work Experience

Freelance consulting

Consultant

September 2021 - Present

Education

PhD in Biotechnology

University of Hyderabad & XIBMS

January 2017 - July 2021

Certifications

Certification details not provided.