Amy Chen Email & Phone Number

Taiwan

Taiwan

• Planning, development and management of Novotech’ s Quality Management System (QMS)• Develop and review of QMS documents• Leading the Operations team to prepare and facilitate the USFDA, NPRA, and TFDA inspections.• Planning and hosting of client audits.• Lead in the investigation and evaluation of quality events (CAPA’s, complaints), incidents and follow-up activities• Lead and perform internal audits, investigator site audits, perform mock inspections• Lead and perform external audits including but not limited to investigator sites, laboratories, CROs, archiving facilities and vendors as part of company vendor assurance program• Participate, review and approve documents for GxP computerized system validation• Participate and present in any client meetings, bid defense meetings as required• Provide GCP and Quality Assurance advice and training to personnel where appropriate• Line management and mentoring of Quality Assurance staff

Taiwan

1. CTMS/ eTMF / PV system and process development and Trainer2. Clinical Operations /Project Management /Risk Based Monitoring related SOP development 3. Quality System Management/ CAPA 4. Perform GCP Site Audits and support Regulatory Inspections5. Business Continuity process development and exercise facilitator

Perform Due Diligence Audit

Taipei City, Taiwan

1. Process related support and quality consultant to Project Leaders and Project Specialists worldwide. 2. Supports project deliverable by acting as problem solving consultant, lead RCA and CAPA 3. Look out for opportunities for overall process improvement while managing project specific Quality Issues. 4. Pparticipated in the initiatives for Risk Based Monitoring 5. Global Project Management SOP author and the SME reviewer for Clinical Operations SOP. 6. Assist with the development of training materials.7. Assist in the maintenance of the relevant website (share point), Project Leader website and PMQM website.8. Develop processes and Quality System for a new business entity handling China stand-alone studies with objective of local registration in China. 9. Prepared and Participated the company system client audits and regulatory authority inspections. 10. Coordinated and facilitated of Business Continuity planning activities across all WW locations, strategic business units and support groups.

Taipei City, Taiwan

1. Served as IMPACT Harmony (Clinical Trial Management System) Process Analyst Lead and IMPACT Harmony Super user coordinator worldwide2. Provided training and established training plans and strategies for Project View (Project Schedule Application) 3. System related SOPs Author4. Served as a quality consultant to operational groups for Technologies. 5. Maintained quality issue (RCA and CAPA) reporting and management process regarding CTMS and Project Scheduling Application. 6. Supported the preparation and participated of external audits and regulatory inspections.

Taipei City, Taiwan

1. System SME for Clinical Trial Management System and Electronic Document Management System 2. Coordinator for Asia Super User for Clinical Trial Related Systems 3. Clinical Trials Related Systems trainer 4. Served as member of the SOP Technical Review Group.5. Provided input during the development of corporate level quality documents, guidelines and templates.6. Ensure compliance with corporate guidelines and templates.7. Ensue an appropriate communication plan exists within CRS APAC such that information regarding controlled documents is communicated appropriately within CRS APAC.

Taipei City, Taiwan

1. Performed administrator/trainer responsibilities focusing on Clinical Trial Management systems, Journyx Time Recording System, and International Document Management and Electronic Archiving System.2. Set up the local Document Management Archiving System3. Developed local Working Instruction4. Event Planner for all Clinical Trial Investigator meetings5. Emergency Backup for Clinical Trial Team: Clinical Monitor Local/CRA Function 6. Clinical Safety Officer Associate7. Support Training Program8. Foreign Guest Reception9. Administration Support to Medical Director10. Provides Clinical Trial Administrative support, including submission dossier preparation, project coordination and project status and milestone tracking. Assisted in Investigator Payment process to ensure tracking of payment triggers.

Bachelor'S Degree, Public Health

Applied Economics

Fundamental Economics

Esol