SInce Jan 2013 , I am associated with Teavpharm India Pvt Ltd , OTC manufacture site near Ahmedabad and responsible for Quality Operation functions . From Sept 2007 - Jan 2012 I worked for Alkem Laboratory and responsible for Quality function of Daman , Baddi and sikkim Plant . Our Daman Facility is apporved by US/UK/TGA /MCC/WHO. 25 years of work experience in the feild of Quality Assurance and Quality control Worked for – STADA Vietnam Nicholas Piramal ,Torrent,Alembic & Pfizer . During these years have been engaged in managing the function of Quality Control, Quality Assurance and validation activity of Formulation as well API plants of Leading Pharmaceutical plants ,who operate domestic as well as regulated markets like US, UK , South Africa , Canada and ROW. Have a experience and knowledge of sterile and non sterile operation of Finished product and API and also involved in the new plant projects from the construction phase. REGULATORY INSPECTION HANDLED: MCC , Irish Medicinal Board, MHRA & TPD - Canada Darmstadt. Germany & USFDA Specialties: QA / QC

Associate Director - QA @ From January 2013 to Present (3 years) Ahmedabad Area, IndiaAssociate Director QA @ From 2013 to 2014 (1 year) Head QA @ From September 2007 to January 2012 (4 years 5 months) Head QA @ From November 2006 to September 2007 (11 months) GM QC @ From October 2005 to November 2006 (1 year 2 months)

Master in Science, MicroBiology @ Gujarat University From 1985 to 1987 Shailesh Patel is skilled in: Validation, FDA, Quality Assurance, Quality Control, Manufacturing, Pharmaceutics, Formulation, Cleaning Validation, Sop, GMP, GLP, Regulatory Affairs, V&V, ANDA, CAPA