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.
MANIKANDAN SUBBIAH
Quality at Biocon Biologics
Bengaluru, Karnataka, India
Overview
Topics They Care 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.
Data Integrity
A core skill is performing data integrity and audit trail reviews, which are critical for maintaining compliance in the pharmaceutical industry.
Media Appearances
MANIKANDAN has no verified media appearances
Work History
8-2021
Quality at Biocon Biologics
8-2018 - 8-2021
Quality control at CAPLIN STERILES
4-2015 - 8-2018
Quality Control at Mylan Laboratories Limited
8-2014 - 4-2015
Production Officer at Hospira
Education
2012 - 2014
Master's degree from Manonmaniam Sundaranar University
More Information
Social Presence :
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Exp : 11
Location : Bengaluru, Karnataka, India
Job Level : N/A
Designation : Quality at Biocon Biologics
