Experience

Unimax Medical Systems Inc.
• Taiwan
• Medical Device
• 1 - 100 Employee
• Regulatory Affairs Specialist

  • May 2023 - Present

Besmed
• Taiwan
• Hospitals and Health Care
• 1 - 100 Employee
• Regulatory commissioner

  • Oct 2021 - Apr 2023


Solara Active Pharma Sciences

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Management Trainee

  • Aug 2018 - Aug 2019

  1.Preparation and Revision of BMR/BPR and SOP's. 2.Software Application’s like SAP (System Application and Product), Track wise, DMS (Document Management System) , SCADA , DCS , HMI, Compliance wire, Origin, and Microsoft office. 3.Handle the OOS, CAPA, Deviation and validations for regulatory audits. 4.Handle QA and production related documents. 5.Materials characterization such as XRD, STEM, IR, DLS, Zeta , TGA and UV. 1.Preparation and Revision of BMR/BPR and SOP's. 2.Software Application’s like SAP (System Application and Product), Track wise, DMS (Document Management System) , SCADA , DCS , HMI, Compliance wire, Origin, and Microsoft office. 3.Handle the OOS, CAPA, Deviation and validations for regulatory audits. 4.Handle QA and production related documents. 5.Materials characterization such as XRD, STEM, IR, DLS, Zeta , TGA and UV.