Experience

Amaran Biotechnology, Inc.

• Taiwan
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Manager

  • Jun 2021 - Present

• Validation/Project Manager

  • Oct 2020 - Present



Intech Biopharm. Ltd 益得生技

• Taiwan
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Manufacturing Technical Services Associate Manager

  • Sep 2018 - Oct 2020

  1. Lead process validation (PV), cleaning validation (CV), study, and scale up of MDI products of the technology transfer products - Help and review the product development report from RD (stage I of product lifecycle) - Prepare PV for TFDA inspection. - Lead and complete CV for the current MDI product. - Design studies for introducing and scale up of MDI products. - Complete the submission batches of MDI products. - Supervise miscellaneous process study and submission documents. 2. Equipment Performance Qualification (PQ) - Lead and complete the performance qualification project of MDI filling and packaging line. 3. Deviation investigation and CAPA plans - Complete the deviation and investigation for the cGMP batches. 4. QMS upgrade for the local plant and Intech - Lead and design the PV/CV upgrade plan for the local plant. - Help revise the change control SOP for Intech Biopharm company- 5. Conduct and lead FMEA (QRM) - Lead and complete FMEA for submission batches and new product introduction plan. Show less



Impax Laboratories

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Senior Technical Services Engineer

  • Apr 2012 - Sep 2018

  1. Technology transfer of products - Complete technology transfer of brand drug and miscellaneous packaging products based on ICHQ10. 2. Process validation (PV) (stage II of product lifecycle) -Responsible for process validation plan and scale up activity of Brand drug (extended release capsule, Rytary) which finally passed FDA and EMA inspection and launched in US market since 2015. -Responsible for process validation plan of packaging line. The packaging line finally passed FDA inspection in 2017. -Prepare miscellaneous PV documents: PVMP, PV protocol, summaries. -Apply statistics methodology (tolerance interval, CpK and PpK) to complete the PV tasks in order to meet the requirement of FDA guidance issued in 2011. -Use lifecycle strategy to complete the PV tasks (stage II of product life cycle). 3. Continued Process Verification - Use statistics approach to complete the product lifecycle (stage III). 4. Equipment Installation/Operation Qualification/Performance Qualification (IOPQ) -Conduct IOPQ of High-Shear Granulator, Extruder, Spheronizer, Glatt GPCG300 PLUS, packaging machines. -Prepare miscellaneous IOPQ documents for execution. 5. Cleaning Validation (CV) -Conduct cleaning validation for all the products in shared equipment. -Prepare CV related document: CVMP, CV protocol, summary. 6. Deviation -Compete the deviation reports to identify the root cause for cGMP batches. -Providing corrective and preventive action plans 7. Meet the Requirement of FDA and EMA Regulation -Proficient in creating process validation plans (SVMP, CVMP, PVMP), technical transfer documents, technical reports which meet the requirement of FDA and EMA regulation. 8. Operation Excellence (OE) Project - Propose and complete OE projects for packaging activities to reduce the cost. 9. Conduct FMEA (QRM) - Complete FMEA for brand drug production and packaging lines. Show less