ABISHEK V
Bengaluru
Summary
Dedicated professional with a strong background in the field of Computer System Validation, Qualification and Calibration in life science sector. Seeking to leverage my strong Analytical skills and regulatory knowledge to ensure compliance and optimize operational efficiency. Committed to maintaining the highest standards of quality and accuracy in validation processes to support critical research and development initiatives.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Executive, QC-Biologics
Syngene international limited
Bengaluru
08.2022 - Current
- Experienced in Computer System Validation (CSV) within GxP-regulated environments, ensuring compliance with regulatory standards including FDA 21 CFR Part 11.
- Executed qualification of laboratory instruments and equipment in compliance with GAMP 5 guidelines, including preparation and execution of IQ/OQ/PQ protocols in GxP-regulated environments.
- Specialised in calibration and maintenance of HPLC and UPLC systems using Empower and Chromeleon software, ensuring data integrity and compliance with GxP and regulatory requirements.
- Developed and Reviewed Standard Operating Procedures (SOPs) within Electronic Document Management Systems (EDMS), ensuring compliance with regulatory standards, proper version control, and timely approval through structured workflows.
- Skilled in the creation of static data using Laboratory Information Management Systems (LIMS) software.
- Expertise in initiating and Managing Change Control and Corrective and Preventive Action (CAPA) processes using TrackWise application
Education
Master of Science - Biotechnology
Kongunadu Arts And Science College
Coimbatore04-2022
Bachelor of Science - Biotechnology
Dr. N.G.P Arts And Science College
Coimbatore05-2019
Higher Secondary -
Trinity Matriculation Higher Secondary School
Coimbatore04-2016
Skills
- Computer system validation
- HPLC/UPLC calibration
- Handling of Empower and Chromeleon software
- Qualification of instruments, equipment
- Regulatory compliance
- LIMS development
- Change control
- Handling of TrackWise application
Languages
Malayalam
Proficient (C2)
C2
English
Proficient (C2)
C2
Tamil
Proficient (C2)
C2
Kannada
Intermediate (B1)
B1
Certification
- Basic Medical coding training using ICD-10.
- Clinical data Management Deep dive. Basics to Advance
HOBBIES
- Keen follower of cricket and football.
- Enthusiast of wildlife and travel, enjoying exploration of natural environments and diverse cultures.
Timeline
Executive, QC-Biologics
Syngene international limited
08.2022 - Current
Master of Science - Biotechnology
Kongunadu Arts And Science College
Bachelor of Science - Biotechnology
Dr. N.G.P Arts And Science College
Higher Secondary -
Trinity Matriculation Higher Secondary School
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