Bhavik Padmani Ms, Rac (Us)
About Bhavik Padmani Ms, Rac (Us)
Bhavik Padmani is the Quality Systems Lead at Alkermes in Waltham, Massachusetts, with extensive experience in quality assurance and regulatory affairs in the biopharmaceutical and medical device industry.
Company
Bhavik Padmani is currently employed at Alkermes, a biopharmaceutical company, in Waltham, Massachusetts, United States. At Alkermes, he plays a significant role as a Quality Systems Lead, leveraging his expertise to ensure compliance and integration of quality systems within the organization.
Title
Currently, Bhavik Padmani holds the position of Quality Systems Lead at Alkermes. His role involves overseeing quality systems and ensuring that they meet regulatory and compliance standards within the biopharmaceutical field.
Education and Expertise
Bhavik Padmani has obtained a Master's degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University, completed from 2014 to 2016. Additionally, he holds an MS in Pharmacology from St. John's University, completed from 2008 to 2011. His expertise spans across process validation, computer system validation (CSV), and performing GAP analysis against regulatory requirements. He is well-versed in managing both internal and external audits and has led multiple projects to improve quality and compliance within the bio-pharmaceutical and medical device industries.
Professional Background
Before joining Alkermes, Bhavik Padmani worked in several roles focused on quality assurance and regulatory affairs. He served as a Sr. Quality Assurance Specialist at Validated Cloud in Waltham, Massachusetts, from 2017 to 2020. Prior to that, he was a Quality Specialist in the Department of Quality Systems at Shire in Lexington, MA, from 2015 to 2017. His earlier career includes positions at Northeastern University as a Graduate Student, and at Beth Israel Deaconess Medical Center as a Research Assistant III and II. Additionally, he gained quality control experience as a Quality Control Officer at Synchron Research Services Pvt. Ltd.
Projects and Initiatives
Throughout his career, Bhavik Padmani has led numerous projects aimed at integrating and implementing quality systems in the bio-pharmaceutical and medical device sectors. He has developed procedures that enhance departmental quality, compliance, and productivity. His comprehensive involvement in process validation, computer system validation (CSV), and conducting GAP analyses against regulatory standards has been pivotal in ensuring compliance and improving operational efficiencies.