Kotresh Hallikeri
@kotreshhallikeri
Experienced CSV Executive with expertise in regulatory compliance.
What I'm looking for
With over 2.6 years of experience in Computer System Validation (CSV), I have honed my skills in ensuring compliance with regulatory standards in highly reputed organizations like Recipharm and Micro Labs Ltd. My journey has equipped me with a robust understanding of US FDA, TGA, and WHO regulatory audits, allowing me to navigate complex validation processes effectively.
In my current role as a CSV Executive in Quality Assurance, I am responsible for managing the entire validation lifecycle, from documentation to audit trail reviews. My expertise includes preparing and reviewing validation documents, conducting risk assessments, and providing technical sign-offs. I take pride in my ability to support internal teams during regulatory audits and ensure that our systems remain compliant and in a valid state.
Experience
Work history, roles, and key accomplishments
CSV-Executive
MicroLabs Limited
Oct 2023 - Present (1 year 7 months)
Currently working as a CSV-Executive in Quality Assurance, responsible for managing the validation process, preparing validation documents, and ensuring compliance with regulatory requirements. Involved in audit preparations and providing technical support for validation projects.
Jr. Executive
Recipharm Pharmaservices Pvt Ltd
Apr 2022 - Oct 2023 (1 year 6 months)
Worked as a Jr. Executive in Quality Assurance, focusing on computerized system validation, conducting monthly audit trail reviews, and preparing various validation documents. Gained experience in regulatory audits and compliance.
Education
Degrees, certifications, and relevant coursework
Kotresh hasn't added their education
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