Jianing Hu
Summary
Results-driven professional with over 5 years of experience in project management and quality assurance within the pharmaceutical and medical devices industries. Knowledgeable, self-motivated, and astute in ensuring exceptional quality standards and successfully managing projects. Experienced in commercial and manufacturing environments.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Commercial Quality Specialist
Johnson & Johnson Singapore
09.2022 - Current
- Successfully lead project NewSEA, establish renewed SEA QMS for Pharm and MedTech segments.
- Collaborate and monitor project tasks for multiple project phases with 6 different markets and ensure deadlines are met.
- Backroom manager, audit coordinator for internal and external audit.
- Support Medical Device and Pharmaceutical segments on execution of quality activities.
- Company Gold Appreciation Award for Feb 2023.
Manufacturing Quality Assurance Trainee
Roche Singapore Technical Operations
03.2021 - 09.2022
- Provide QA oversight for RSTO to ensure products are manufactured in accordance with global Roche, Pharmaceutical Quality System (PQS) and local site requirements.
- Responsible for escalation of quality issues following the criteria defined in current governing documents.
- Support and perform routine “Make, Assess, Release” operations to meet targets and timelines in GMP environment.
- Participated in the design and implementation of department and cross-functional Kaizen project such as retire Quality Tag-Out procedure to achieve continuous improvement of production.
- To undertake additional responsibilities as required by Quality Management to meet business needs.
VP Operation & Product Development
Pathnova Laboratories Pte Ltd
12.2017 - 11.2020
- Co-invented, patent and publish Deep Learning-Fuzzy Inference (DeLFI): an interpretable model for detecting indirect immunofluorescence patterns associated with nasopharyngeal cancer. PMID: 35750258, DOI: 10.1016/j.ajpath.2022.05.010
- End to end development and validation new nasopharyngeal cancer (NPC) detection product for use by clinical customers.
- Applied comprehensive understanding of GMP, ISO 15189 and ISO 13485 to optimize designs.
Assistant Research Officer
Temasek Lifesciences Laboratory
12.2017 - 11.2020
- Performed in-vitro and in-vivo experiments and research over course of 2 years to test for liposomal encapsulated aurora kinase drugs release and documented all findings.
- Troubleshot problems by improve experimental design for proper actions and expanded improvement initiatives.
- Supervised research progress of NUS students and demonstrated proper cell culture and animal experiment techniques for youngsters resulting in improved skills.
Education
Master of Science - Chemical Engineering
National University of Singapore
Singapore06.2021
Bachelor of Science - Chemical Engineering
Technical University of Munich
Germany06.2017
Skills
cGMP
QMS
Quality assurance
Quality mindset
Audit management
Procedural writing
Records maintenance
Product quality complaint
Project management
Planning and coordination
Communication skill
Data analysis
Certification
- Compliance Academy Audit Training Workshop
- Johnson & Johnson Regulatory Compliance (JJRC), Compliance Academy – Auditing Management Certification
- LinkedIn Certificate – Become a Six Sigma Black Belt
- LinkedIn Certificate – Become a Six Sigma Green Belt
- LinkedIn Certificate – Become a Six Sigma Yellow Belt
Languages
English
Advanced (C1)
Chinese (Mandarin)
Bilingual or Proficient (C2)
Timeline
Commercial Quality Specialist
Johnson & Johnson Singapore
09.2022 - Current
Manufacturing Quality Assurance Trainee
Roche Singapore Technical Operations
03.2021 - 09.2022
VP Operation & Product Development
Pathnova Laboratories Pte Ltd
12.2017 - 11.2020
Assistant Research Officer
Temasek Lifesciences Laboratory
12.2017 - 11.2020
Master of Science - Chemical Engineering
National University of Singapore
Bachelor of Science - Chemical Engineering
Technical University of Munich
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