Quality Assurance Manager
Alive Pharmaceuticals Pvt. Ltd
"Along with the main role of Engineering, I handled various other functions like Projects, Validations/Qualifications, Automation, Instrumentation and Calibration. I have been into Engineering role since beginning of my career. I started as Management Trainee with Cadila Pharmaceuticals after working as a Programming Engineer at Mitsuibishi System House in Ahmadabad. Have done programming of various equipments and moved to Cadila Pharma (Dholka Plant) with Engineering responsibilities. Later moved into higher roles at Dr Reddy’s (Biologics Division) and Kemwell Biopharma Pvt. Ltd. (Biopharma Unit). The Engineering role involved various aspects – Black Utility Equipments, Clean Utility Equipments, HVAC, Process Equipment Maintenance, Preventive Maintenance, Breakdown Maintenance, Statutory Compliance, GMP Compliance, Inventory Management, GMP Documentation – SOPs, CCF, Deviations, CAPA etc. As part of Audit Compliance I played lead role from Engineering function in handling Audits by various international regulators, customers & business partners. The major audits faced are MHRA, ANVISA, WHO GMP, GCC. This activity involved checking day-to-day compliance to Engineering Systems."