Mathanraj has 15 years of combined experience in pharmaceutical, medical device manufacturing process, equipment, engineering and facility design, qualification, validation and operations. He is an experienced and pragmatic project engineer with proven track record in managing multiple projects across multiple disciplines and stakeholders of all levels. His skills have been developed through pharmaceutical operational, quality engineering and project management experience, leading the commissioning, qualification and validation for investment projects of new plant implementations and plant expansions for pharmaceutical companies, regulated by FDA, EU, CFDA and PIC/s.
University of South Australia, Singapore
Master of Engineering - Engineering and Technology Management (GPA 5.95 out of 7)
Development of concept design, basic design, detail design for facilities, utilities and equipment. Lead project stage gate GMP reviews. Managed stakeholders at different level site, divisional, global together with multiple equipment suppliers. Managed development of URS, risk asses sment, DQ, commissioning, IQ, OQ, PQ and execution for plant expansion and new plant and manage the activities to meet the scheduled dates. Member of Bayer, C&Q community to establish methods, templates, best practices to standardize the project execution across APAC region. Lead auditor for GMP audits for contract manufacturers as per global GMP audit program.