I am a trained professional with 20 years combined experience in Bio pharmaceutical quality including facility start-up, technology transfer (Clinical and commercial) and regulatory GMP inspections (Multiple PAI inspections by EMA, USFDA). Working in CMO has provided exposure to number of large pharmaceutical company quality system requirements and customer handling experience. Ability to hire, retain staff through training, performance management, coaching and development. Quality control expertise: Lab equipment Qualification, Water system qualification, Method Validation, Method transfer, Lab Investigations, Environmental monitoring, EM excursion investigations, Aseptic manufacturing requirements, Aseptic Process Validation, Isolator technology etc., Quality Assurance expertise: Expertise in ability to implement and maintain various quality management systems such as Deviation Management, CAPA Management, Change Management, Batch disposition management, Master Batch record Management, Audit hosting.

Senior Department Manager-QA @ From July 2013 to Present (2 years 6 months) QC Manager @ From October 2010 to June 2013 (2 years 9 months) Quality Supervisor @ From November 2006 to October 2010 (4 years) Microbiologist @ From January 2003 to November 2006 (3 years 11 months) Executive (Quality Control) @ From April 2000 to January 2003 (2 years 10 months) Senior Technician @ From August 1995 to April 2000 (4 years 9 months)

Bachelor of Science, Microbiology @ University of Madras From 1991 to 1994 Master of Business Administration @ Madurai Kamaraj University Arivazhagan Ramamoorthy is skilled in: Quality Assurance, GMP, Quality Control, Validation