MANIKANDAN SUBBIAH
Quality at Biocon Biologics
📍 Bengaluru, Karnataka, India
Manikandan is a Computer System Validation (CSV) Specialist with over 10 years of experience in pharmaceutical quality assurance and IT compliance. He is skilled in validating GxP systems and ensuring adherence to regulatory standards like 21 CFR Part 11 and GAMP 5. He holds a Masters degree from Manonmaniam Sundaranar University.
He is actively seeking new opportunities and has indicated he is available for immediate joining.
Read the full overview →Experience
11 Years
Current Role
Quality
Location
Bengaluru, Karnataka, India
Personality Overview
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Priorities
Topics MANIKANDAN cares about
Pharmaceutical Compliance
His expertise is centered on ensuring GxP systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5 for agencies like the USFDA, EMA, and MHRA.
System Validation
Manages the entire system lifecycle from planning to retirement, creating key validation deliverables like URS, IQ, OQ, PQ, and risk assessments for systems such as LIMS and ELN.
Career
Work history
8-2021
Quality
Biocon Biologics
8-2018 - 8-2021
Quality control
CAPLIN STERILES
4-2015 - 8-2018
Quality Control
Mylan Laboratories Limited
8-2014 - 4-2015
Production Officer
Hospira
In the press
Media appearances
No media yetWe could not find public media appearances for this person.
Education
2012 - 2014
Master's degree
Manonmaniam Sundaranar University
Social presence
Other Biocon Biologics Employees
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