Ashwinkumar Erandole Email & Phone Number

14+ years in pharmaceutical sterile injectable & Biologics, Quality Control (QC) and Quality Assurance (QA) professional passionate about ensuring the safety, efficacy, and compliance of life-saving products. Currently work as an Associate Manager at Biocon Biologics India Limited, Bangalore. I am responsible to handle quality management systems (QMS), Deviations, CAPAs, Risk Assessments, Audits, and Microbiology Investigations.Throughout my career, I have contributed in regulatory inspections as an first line, such as US-FDA, MHRA, ANVISA, MCC, TGA, etc. I involved in QA/QC Quality improvement initiatives, such as Cleaning Validation, Aseptic Process Simulation (Media-Fill) management, and cGMP. To further enhance my skills and knowledge, I am pursuing an MBA in Quality Management System from BITS Pilani, a prestigious institution in India. My goal is to apply my expertise and leadership to support Biocon's mission of delivering affordable and innovative biologics to the global market.