Aswath Thimmaiya
Coimbatore
Summary
Accomplished Engagement Lead at Zifo RnD Solutions, expert in software validation and adept at leading complex projects across global teams. Demonstrated success in devising validation strategies, enhancing compliance with 21 CFR regulations, and driving project delivery. Skilled in TOSCA and collaborative project management, consistently delivering customer satisfaction and operational excellence.
Overview
5
5
years of professional experience
Work History
Engagement Lead
Zifo RnD Solutions
09.2019 - Current
- Led validation projects on various systems in regulated environment (GLP and GMP) such as LIMS, ELN, Quality management systems, training management systems for customers from different geographical locations and collaborated with different teams
- Devised validations strategy for complex projects based on CSV and CSA approaches, performed risk assessment and compliance assessment.
- Managed delivery for customers. Authored validation documents such as Change control, Validation Plan, Functional Risk Assessment, Gap Assessment, Compliance assessment, User requirements, Functional requirements, IQ/OQ/PQ scripts, established traceability, Validation Summary report.
- Possess knowledge on various regulations such as 21CFR Part 11, EU Annex 11, 21 CFR Part 58, PICs, GDPR.
- Authored process documents such as SOP and Work Instructions
- Experienced in Automation tools such as TOSCA, Katalon
- Collaborated and developed SoW documents, prepared estimations and proposal for customer projects, analyzed the efforts spent on project and managed billing activities
Education
Bachelor of Science - Microbiology
Karpagam University
Coimbatore04.2019
Skills
- 21 CFR regulations
- Software Validation
- Test protocol and Test Management
- Expertise in LabWare, AgiLab, LabVantage, Sample Manager LIMS, SAPIO Exemplar
- Expertise in IDBS ELN
- Expertise in HP ALM, JIRA, Azure DevOps, Test rail, qTest, KNEAT
- Expertise in TOSCA and Katalon
- Expertise in Postman API testing
Timeline
Engagement Lead
Zifo RnD Solutions
09.2019 - Current
Bachelor of Science - Microbiology
Karpagam University
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