Thanigaivel Pandurangan
Devens,MA
Summary
Experienced Quality Management System (QMS) Subject Matter Expert (SME) with over 15 years of dedicated service in the pharmaceutical industry. Proven track record of designing, implementing, and optimizing robust QMS frameworks to ensure compliance with regulatory standards and drive operational excellence. Adept at leading cross-functional teams, conducting thorough risk assessments, and providing strategic guidance to streamline processes and enhance product quality. Strong communicator with a passion for fostering a culture of continuous improvement and regulatory adherence. Dedicated to upholding the highest standards of quality and safety within highly regulated environments.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Sr. System Engineer
Moderna
07.2020 - Current
- Implementation Lead for QMS, QDocs workflows and Integrations
- Strong Quality Management System process like Change Control, Deviations, Proactive Initiatives, Complaints, Audits, Document Workflows
- Good understanding of Regulatory Information Management Systems
Manager - Projects
Cognizant Technologies Solutions
10.2012 - 07.2020
QMS Technical Lead for Major Pharmaceutical Clients like Philips, AbbVie and Vertex
Lead Support and Development team to maintain QMS Applications and Projects
Sr. Associate Projects
Cognizant Technologies Solutions
11.2009 - 10.2012
QMS Technical Lead for Major Pharmaceutical Clients like Merck and Philips
Lead Support and Development team to maintain QMS Applications and Projects
Sr. Software Engineer
Covansys - A CSC Company
11.2005 - 11.2009
Participate in requirements gathering
Analyze and identify gaps in requirements
Design and Develop Web Applications
Support MS.Net based web applications
IT - Administrator
Ambience Associates
02.2005 - 11.2005
Provide windows based computer / desktop support
Update Patch and resolve any computer issues
Developer
Plenus Solutions
01.2004 - 02.2005
Participate in requirements gathering and analysis
Develop Web Applications
Perform Unit Testing
Education
MBA - Systems
Periyar University
Salem, Tamil Nadu, India2008
Bachelor of Engineering - Electronics And Instrumentation
Annamalai University
Chidambaram, Tamil Nadu, India05.2003
Skills
- Quality Management Systems (Veeva QMS & Trackwise QMS)
- Oracle and MS-SQL Query
- Regulatory Management System (Veeva RIM)
- JIRA, ServiceNow, Visio, Microsoft Project Plan
- Postman for API, Net, HTML
Certification
- Certified Veeva Platform Associate Administrator
Additional Information
Veeva Platform Associate Administrator
Credential ID: CER-125131
Expires On: Dec 31, 2024
Languages
English
Full Professional
Tamil
Full Professional
Timeline
Sr. System Engineer
Moderna
07.2020 - Current
Manager - Projects
Cognizant Technologies Solutions
10.2012 - 07.2020
Sr. Associate Projects
Cognizant Technologies Solutions
11.2009 - 10.2012
Sr. Software Engineer
Covansys - A CSC Company
11.2005 - 11.2009
IT - Administrator
Ambience Associates
02.2005 - 11.2005
Developer
Plenus Solutions
01.2004 - 02.2005
MBA - Systems
Periyar University
Bachelor of Engineering - Electronics And Instrumentation
Annamalai University
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