CPIM (Certified in Production and Inventory Management)
Hwang JungYu
Subject Matter Experts In The Process Engineering And Talent Who Can Create Synergy In The Organization Through Effective Communication, Work Experience Of Quality And Business Area
Yongin City ,Gyeonggi
Summary
Dedicated pharmaceutical industry professional with 16 years of Process engineering, Quality, Business work experiences of meeting company goals utilizing consistent and organized practices. Proactive and passionate project leader added servant leadership to meet company's goals.
Overview
16
16
years of professional experience
11
11
years of post-secondary education
Work History
PES (Partnership & External Supply) GROW Program
Janssen Korea
Hwasung , Gyeonggi
03.2021 - 12.2021
- Drove agile product launch process setting and achieved successful product launch as the first EM site in Korea -Set the systematic delivery and incoming process from EM site to Janssen Korea distribution center through deep dive of workstream review
-Enabled both parties’ stakeholders to monitor current workstream through on-time manufacturing and delivery status monitoring board execution - Managed compliance issues through deep expertise as an experience of technical SME (Subject Matter Expert) -Supported EM site audit preparation on Janssen global audit team: proactively supported EM site: enabled immediate response to the auditor's observations on the justification of the PAR (Proven Acceptance Range) setting
-Managed foreign material issue in main excipient: Led collaboration of EM-Janssen-Supply relevant departments and executed the risk assessment on foreign materials. Completed the issue without any impacts on product quality and supply in the market
Staff Engineer of Technical Operation
Jnassen Korea
Hwasung , Gyeonggi
10.2018 - 12.2021
- Led Technical Transfer of Janssen products from Janssen Korea to EM (External Manufacturing) site -Conducted gap and risk assessment for entire equipment and unit process of both site (Janssen vs EM site)
-Supported Pharmaceutical Equivalent Test strategy for Korea MFDS (Ministry of Food and Drug Safety) application
-Led process parameter setting based on QbD (Quality by Design) from Technical to Commercial batches
-Participated in CTD (Common Technical Document) preparation on manufacturing process development part
-Executed Distribution Test (based on ASTM D-4169) for the Ultracet products through collaboration of SGS Korea
: validated the transportation method and packaging configuration for the products - Guided EM site CPV (Continued Process Verification) implementation as a APAC CPV council member -Proactively supported to set the EM site’s CPV strategy and guided SOP, Protocol preparation
-Completed successful CPV implementation to meet Janssen global CPV standards for the first time in Korea - Managed the process and quality improvement project of Tylenol, Ultracet groups -Led project team for Tylenol 500mg compression process stabilization with a 6% of compression yield increase,
a process lead time reduction, zero quality issue and assured reliable product supply in COVID-19 pandemic -Conducted Tylenol ER Dissolution rate stabilization through regular monitoring process and trend prediction, a result in zero quality issue and batch disposal -Performed Ultracet ER coating quality improvement for preemptive prevention of customer complaint, which achieved zero quality issues and led the 5% of coating yield increase: suggested a cost and time saving strategy through solid collaboration of global Modeling group
Supervisor of Operational QA
Janssen Korea
Hwasung , Gyeonggi
09.2017 - 10.2018
- Managed customer complaint as a site quality representatives: with the full collaboration of local and global team -Led the local product quality investigations on customer complaints and reported the trend analysis to Complaint Investigation Oversight Group
-Guided the CAPA (Corrective and Preventive Action) execution and reviewed the result - Performed site internal audit execution and quality culture establishment as a certified site internal auditor -Directed the improvement points of the internal site team through periodic shop floor activity -Actively supported manufacturing team to enhance quality mindset and establish quality culture: provided regular quality activities to entire operators
- Achieved an effective and time-saving response on Quality Issue investigation -Led the intermittent product quality issue investigation as a representative QA on Formulation, Warehouse team:
achieved about 10% of investigation time saving through QI council operation meeting Janssen global standard and effective CAPA actions
Team Manager of Technical Team
Daewon Pharm.
Hwasung , Gyeonggi
10.2016 - 09.2017
- Devoted technical transfer workstream set and led successful product transfer from R&D center to Site -Contributed to technical transfer policy establishment and restructured new process on product transfer: resulted in
significant shortening the development timeline
-Suggested operation of Technical team in manufacturing site for the main role of product transfer: successfully led the team as a manager with most efficient and agile manners - Managed the entire new product launching time schedule as a site representative and council leader -Proposed and managed the operation of the new product progress council: achieved flawless on-time launch progress by encompassing efficient communication with marketing, R&D, RA, Quality, Planning, and Production departments
Team Manager of Technical Operation
Hanmi Pharm.
Hwasung , Gyeonggi
04.2008 - 10.2016
- Drove QbD (Quality by Design) based process study with the collaboration of multinational company -Executed Technical Risk Assessment with GSK technical team (Metformin/Rosuvastatin Ca complex): contributed to reach agreed mitigation strategy before clinical batch manufacturing
- Led technical transfer activities as a part of global business project -Led Hanmi Paltan site to Beijing Hanmi transfer: Amorzartan process setting for clinical test batch
-Led Hanmi Paltan site to Catalent (Kentucky, USA) transfer: Esomeprazole process setting from Feasibility to PV batch
-Led Hanmi Paltan site to En-cap (Edinburg, Scotland) transfer: Paclitaxel process setting for the clinical test batch - Delivered new products launching time schedule management as a site representatives -Proactively led the new product launching council (Marketing, R&D, RA, Quality, Planning, Production) with end to end mindset: resulted in on-time market launch -Monitored regulatory progress from BE (Bioequivalence) Test result to MFDS Approval
- Managed the entire Scale Up and Post Approval Changes for Oral Solid Dosage Formulation as a project leader -Actively led and managed SUPAC relevant projects; process innovation and cost-saving project, feasibility test for 2nd source (APIs, Excipients), batch scale-up, down/ troubleshooting, OTC formulation study
Team Member of QA
Hanmi
Hwasung , Gyeonggi
04.2006 - 04.2008
- Delivered manufacturing process monitoring and contributed to the early stage of GMP standard-setting in site -Led the regular GEMBA work on manufacturing area and actively contributed to site GMP upgrade as a GMP council member
.
Education
High School Diploma -
Ogum High School
Seoul 03.1993 - 02.1996
Associate of Science - Chemistry
University of Kyung-Hee
Suwon City 03.1998 - 02.2006
Skills
Technical Transfer
Process Improvement
Quality Investigation
Project Management
People Management
Problem Solving Skill
Communication Skills
Team Building Skill
GMP Documentation
Quality by Design
Production and Inventory Management
Continued Process Verification (CPV)
Statistical Skills
Accomplishments
1. Flawless and successful product transfer from Janssen to Korea EM site
2. Set the solid and systemic delivery system between Janssen to Korea EM site
3. Process and Quality improvement of Tylenol, Ultracet group
(Yield increase, Customer Complaint prevention)
Affiliations
APAC Continued Process Verification Council member (Janssen)
Interests
Timeline
PES (Partnership & External Supply) GROW Program
Janssen Korea
03.2021 - 12.2021
Staff Engineer of Technical Operation
Jnassen Korea
10.2018 - 12.2021
Supervisor of Operational QA
Janssen Korea
09.2017 - 10.2018
Team Manager of Technical Team
Daewon Pharm.
10.2016 - 09.2017
Team Manager of Technical Operation
Hanmi Pharm.
04.2008 - 10.2016
Team Member of QA
Hanmi
04.2006 - 04.2008
Associate of Science - Chemistry
University of Kyung-Hee
03.1998 - 02.2006
High School Diploma -
Ogum High School
03.1993 - 02.1996