Ivan Yu Email & Phone Number

Singapore

Singapore

Operations QA

Deviations, CAPAs, Complaints, Recall & Document Management SME

Singapore

Audits and Inspections SME

Led Inspection Prep Room for successful EMA and FDA facility Pre-Approval Inspection

Singapore

Site lead for Change ManagementLead and coordinate change controls to ensure alignment of regulatory filings with experience in APIs and Sterile Products.Tracking and recording of activities associated with regulatory submissions.Provide support to licence holder and liaise with local authorities pertaining to licence application/renewalSupport Global Regulatory Affairs with submissions and processing of post-approval changes.Conduct internal audits for site facilities.Manage audits by health authorities and customers.

Quality Associate in Product Release, Singapore Biotech Facility.Release of both raw materials and finished products.SAP UserLIMS Superuser.SAP-LIMS Interface Project TeamProject lead in cost-savings initiative which led to US$500,000 annual savings.

Section Head of Refining.Led team of 16 technicians.In charge of all issues pertaining to daily operations such as material planning, purchasing, engineering and maintenance works & shift planning