Che-Jen Wu Email & Phone Number

Tainan City, Taiwan

1. Achieved the compilation of 3 pharmaceutical projects for variation purposes.2. Coordinated due diligence and assisted in planning strategies of 14 in-licensing projects from EU, CN, IN, and KR to APAC for MA applications in 2022.3. Participated in 2 conferences and shared the up-to-date industrial news with RA colleagues.4. Provided support to the quality department in facilitating compliance with cGMP requirements.5. Managed more than 3000 artworks and raised 12 change… Show more 1. Achieved the compilation of 3 pharmaceutical projects for variation purposes.2. Coordinated due diligence and assisted in planning strategies of 14 in-licensing projects from EU, CN, IN, and KR to APAC for MA applications in 2022.3. Participated in 2 conferences and shared the up-to-date industrial news with RA colleagues.4. Provided support to the quality department in facilitating compliance with cGMP requirements.5. Managed more than 3000 artworks and raised 12 change controls in 3 months.6. Established or improved working procedures such as control of product information & registered indications, in-licensing projects kickoff procedure, and artwork revision procedure.7. Trained 3 new colleagues on method/process validations and their related documents reviewing. Show less

Tainan City, Taiwan

1. Sample 15 batches of IPC materials per week.2. Assure 7 manufacturing lines/operations that comply with cGMP requirements each day.3. Review 20 batch records’ completeness and accuracy per week.4. Write up 2 discrepancy reports (deviations, root cause analysis, CAPAs) of manufacturing per month and oversee change controls.5. Prepare and implement 1 clean validation protocol and issue the report per month.6. Translate annual product reports, SOPs, documents for… Show more 1. Sample 15 batches of IPC materials per week.2. Assure 7 manufacturing lines/operations that comply with cGMP requirements each day.3. Review 20 batch records’ completeness and accuracy per week.4. Write up 2 discrepancy reports (deviations, root cause analysis, CAPAs) of manufacturing per month and oversee change controls.5. Prepare and implement 1 clean validation protocol and issue the report per month.6. Translate annual product reports, SOPs, documents for registration of medicinal products.7. Supported audit activities (TFDA, Pfizer, Sawai) in the past year.8. Lecture on PIC/S GMP in the QA department once a month. Show less

London, England, United Kingdom

1. Utilised bilingual advantages and CRM to maintain 100+ client relationships per day.2. Ranked in the top three sales (£2,500/day) and achieved objectives and KPIs with the team.3. Proactively assisted in training 5 new team members in the flagship store.4. Experienced communicating in an international environment with cross-cultural sensitivity.

Tainan City, Taiwan

1. Familiarised 5 junior analysts with the laboratory routine tasks and PIC/S GMP regulations.2. The superintendent of 500-ish columns and 100-ish liquid reagents for value-based management.3. Assisted in modifying testing methods and issuing method validation reports.4. Executed transfers of new product analytical methods into the QC laboratory with the R&D team.5. Performed OOS/OOT investigations and CAPAs with the QA team.6. Completed testing 10 batches of the finished… Show more 1. Familiarised 5 junior analysts with the laboratory routine tasks and PIC/S GMP regulations.2. The superintendent of 500-ish columns and 100-ish liquid reagents for value-based management.3. Assisted in modifying testing methods and issuing method validation reports.4. Executed transfers of new product analytical methods into the QC laboratory with the R&D team.5. Performed OOS/OOT investigations and CAPAs with the QA team.6. Completed testing 10 batches of the finished product in various dosage forms per week.7. Assigned to conduct analyses of emergency cases for manufacturing on that day.8. Performed on-site tests for TFDA inspection. Show less

Tainan City, Taiwan

1. Responsible for aseptic simulations (media fills), facility cleaning, site material transfer, site aseptic behavior, and site gowning programs.2. Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, SOPs, and industry practice.

Tainan City, Taiwan

1. Manufacturing operations of chemical synthesis.2. Maintenance and troubleshooting of manufacturing equipment.

Master Of Science - Ms, International Business And Development

1. Development Policy 2. Economics for Managers 3. International Business and Economic Development 4. International Business Ethics 5..

Bachelor Of Science - Bs, Chemical Engineering

Had been the Scout Club leader and held some extracurricular activities such as mountain climbing, camping, volunteer services, etc. One.