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Suresh Govindasamy

Suresh Govindasamy

Validation Engineer (CSV)

Pharmaceutical / Bio-tech

Scarborough, Ontario

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About Suresh Govindasamy:

5+ Years of experience in Computer System Validation (CSV) & IT Compliance. Expertise in GAMP guidelines and good knowledge of GxP Analysis, 21 CFR Part 11 (USFDA), EU Annexure 11. Having good experience in both V- Model and Agile Methodology. Good knowledge of Retirement of the GxP systems. Good Experience in Handling defects, deviation, Change control, and CAPA. Provide compliance assurance services for the applications that fall under GxP. Understand corporate standards and processes regarding infrastructure maintenance and deployment and assist local IT service providers in executing the processes. Develop a process to monitor the systems to make sure it is performing in line with the regulatory requirements and meet the customer needs. Act as a primary contact for all the end users. Assist in the development and tracking of accurate and relevant information security processes and operational metrics. Understand relevant business processes and their implications on the Validation process and guided them to meetthe requirements withoutdeviating from the compliance procedure.

Experience

5+ Years of experience in Computer System Validation (CSV) & IT Compliance. Expertise in GAMP guidelines and good knowledge of GxP Analysis, 21 CFR Part 11 (USFDA), EU Annexure 11. Having good experience in both V- Model and Agile Methodology. Good knowledge of Retirement of the GxP systems. Good Experience in Handling defects, deviation, Change control, and CAPA. Provide compliance assurance services for the applications that fall under GxP. Understand corporate standards and processes regarding infrastructure maintenance and deployment and assist local IT service providers in executing the processes. Develop a process to monitor the systems to make sure it is performing in line with the regulatory requirements and meet the customer needs. Act as a primary contact for all the end users. Assist in the development and tracking of accurate and relevant information security processes and operational metrics. Understand relevant business processes and their implications on the Validation process and guided them to meetthe requirements withoutdeviating from the compliance procedure.

Education

I Graduated with a Bachelor of Technology (Electronics & Instrumentation Engineering) from Pondicherry Engineering College, India in 2017.

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