Prosenjit Das

Experience

1. Manager Qara

   Align Technology

   Jul 2024 — Present

   Develop and maintain quality management system and to comply with Align Global Quality framework, local requirement, Global QMS Policies and Global Standard Operating Procedure. Selection review and monitoring of CMO and 3 PL Site. Implementation and monitoring of QMS System in the CMO & 3PL site and Performing vendor onboarding in Aravo. Implement the quality audit program and perform internal and external audit. Develop and maintain CAPA activities, investigation, root cause analysis, Deviation, change control management. Act as an India single point of contact with Global team, for Quality and Regulatory related matter Drug and Medical Device in India.(Reporting to APAC Quality team in Singapore) Review and approval of QMS documents i.e Change Control and Risk management document. Performing as MR Role for India and conducting quality management review. Handling of Complaint management System and providing query response for complaint. Preparing monthly dashboard and metric related Product complaint and conducting Complaint Board meeting. Conducting monthly training session to all employees related to GXP & QMS related topic Preparation and handing of Product licensing document i.e Device Master File as per FDA & India MDR 2017. Handling of difference automated system Arena, Track wise, Aravvo, Ariba, LMS for QMS topic etc. Coordination with Global Regulatory for imported Product (Drug & Medical device) in India. Handling of FDA query and providing appropriate response. Implementation of Good Distribution Practice throughout CFA and warehouse & 3PL site. Handling of FDA query and providing appropriate response.

Skills

• Pharmaceutical Industry
• Sop
• Fda
• Recruiting
• Software Documentation
• Glp
• Quality System
• V&V
• Regulatory Affairs
• Lims
• Cleaning Validation
• Formulation
• Quality Assurance
• Gmp
• R&D
• Validation
• Change Control
• Testing
• Capa