EXPERT OPPORTUNITIES

Balaji Venkatnarayanan

Quality Assurance I Clinical Development

Status:

12 month points:

Total points:

Novice
57
57

Awards earned

0

Gold

0

Silver

0

Bronze

menu Summary


Experienced Healthcare and Pharmaceutical Quality management professional with progressive career, responsible for the providing support to improve the quality of the healthcare deliverable in research patients. Also responsible for continual innovation to provide high quality research benefits to patients to improve the quality of life in the trial environment.
• Pharmaceutical Research and Development
o (Clinical, Data Management, Pharmacovigilance and Supply Chain Quality)
• Manufacturing and Out Sourcing
• Quality Assurance Program Management
• Investigator Site Quality Management
• Merger & Acquisition Integration from QA perspective



Contact: vbalaji9182@gmail.com

work Experience

Abstract Reviewer

Society of Quality Assurance

November 2016 - Present

Review of Clinical QA related abstracts

Active Member

Society of Quality Assurance

August 2016 - Present

Clinical, Pharmacovigilance and Mentor committee

Manager - Quality

PRA Health Sciences

August 2016 - Present

Strategic and Tactical Management of QA activities across Europe, Middle East, Africa and Asia Pacific including India, Japan, and China .
Managing Audits,
Consulting, Mentoring, Resource/team Management.

Member

RQA

January 2010 - Present


Domains of experience:

Computer System Validation
Pharmacovigilance
FDA
Clinical Trials
Sop
21 CFR Part 11
GCP
Oracle Clinical
GMP
ICH-GCP
Quality Assurance
CRO
Clinical Research
Pharmaceutical Industry
Quality System
Validation
GLP
Regulatory Affairs
CAPA
GxP
Clinical Development
Quality Auditing
Change Control
Regulatory Submissions
Biotechnology
Quality Control
CTMS
Pharmaceutics
U.S. Food and Drug Administration (FDA)
Good Clinical Practice (GCP)
Standard Operating Procedure (SOP)
CRO Management
U.S. Title 21 CFR Part 11 Regulation
Clinical Trial Management System (CTMS)
stars Convetit Experience

Recent Open Board Activity:

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Asked a question on the "Future of Block Chain Technology as it pertains to Health care" Open Board

Blockchain Technology
Blockchain Technologies
Healthcare
Healthcare Information Technology
Distributed Ledger Technology
Healthcare Industry
Health Insurance
Block Chain health