Justine Chua Email & Phone Number

Singapore

Singapore

Singapore

Singapore

- Subject Matter Expert for Quality Management Systems- Lead 3rd-party audit activities (e.g. pre-audit planning, audit readiness, post-audit follow-ups, etc.)- Conduct and support 2nd-party audit activities (e.g. supplier audit, customer audits) - Responsible for Internal Audit activities (e.g. training, scheduling, planning, execution, closure, etc.)- Support Quality Management Review activities- Responsible for revising, execution and maintenance of all QMS processes (e.g. CAPA, Complaints, NC, Supplier management, Training, etc.)Key achievements- Established and implemented eQMS platform from paper-based QMS within 6 months- Identified, established and implemented the processes required for ISO 13485 scope expansion within 3 months- Successfully obtained ISO 13485 scope expansion certification- Established QMS training material for New Hires within 2 months- Identified the company training needs and organised Risk Management training by external vendor

Singapore

- Subject Matter Expert on QMS & Compliance - Key contact for all Quality Management Systems (QMS) relevant processes for Singapore Site- Liaison between HQ and local cross-functional teams for assessing change impact to QMS- Building organisation Quality culture through conducting compliance training on New Hire Orientation- Manage action items from Quality Management Review- Conduct internal audits, ensured timely completion of action items

Singapore

- Investigate product/ process-related deviations- Manage all sterilization-related activities (EO sterilization and E-beam irradiation) to ensure compliance with ISO 11135, and ISO 11137.- Manage sterilization service providers, external test laboratory service providers, and raw material supplier- Strengthen and manage site-wide CAPA system- Established change control management board- Subject Matter Expert and key auditee for sterilization-related topics, and CAPA management topics

Singapore

- Involve in Good Manufacturing Practices (GMP) audits- Involve in results verification- Involve in routine testing (including bioburden test, growth promotion test (GPT), biological indicator (BI) test, microbial identification test, endotoxin test and environmental monitoring of compressed gas)- Proficient and have good knowledge on bioburden testing of raw materials, water and in-process samples- Proficient in microbial identification testing and reviewing- Constantly reviewing and revision on Quality Control (QC) laboratory-related standard operating procedures (SOPs)- Actively lead and support continuous improvement initiatives- Track and manage QC-microbiology department related change control and deviation records- Initiate and execute related protocols/projects- Writes protocol, report and perform execution of equipment qualification- Mentor and train team members on-the-job- Guiding and leading of shift team on weekends- In charge of 5S of gowning room

To perform research on the effectiveness of endotoxin removal from protein solution.To perform data refining and processing to study the effectiveness of endotoxin removal._________________________________________________________To assist in cell culture media optimization from shake flask scale to 2L bioreactor scale.To collect and analyze data of cell performance in the different media.

Bachelor'S Degree (Hons), Biological Sciences, 2Nd Upper Honors

Activities and Societies: Research Exercise Program (Non-mandatory)/internship Structural Biology & Biochemistry Division, Nanyang.

Diploma In Biotechnology, Biotechnology