Angela Chua
Summary
Results-oriented achiever with proven ability to exceed targets and drive success in fast-paced environments. Pursuing full-time role that presents professional challenges and leverages interpersonal skills, effective time management, and problem-solving expertise.
Overview
14
14
years of professional experience
Work History
Senior Quality Assurance Specialist (Compliance)
Pfizer Asia Manufacturing Pte Ltd
08.2022 - Current
- Oversee adequate quality oversight to supplier management to ensure starting materials used meet requirements.
- Qualify suppliers and maintain accurate records of supplier status. Review and analyze the quality related issues from suppliers and recommend improvement actions to mitigate compliance risk.
- Appointed for Quality Risk Management (QRM) Master Register on identifying the risk assessments under Vendor Management. Manage risk effectively by proactively addressing potential issues and proposing potential site remediation plan before they became critical problems.
- Ensure supplier and material is qualified by collaborating with cross-functional departments to ensure production schedules met.
- Perform supplier site visits and establish quality agreement between organization and supplier.
- Review agreements and negotiate with suppliers to obtain favorable terms and conditions, and to confirm compliance with company policies and procedures.
- Foster a culture of continuous improvement within Vendor Management & Procurement teams, driving improvements in efficiency and effectiveness.
- Conduct external audits to ensure adequate oversight to suppliers and collaborate with supplier to reduce starting material quality issues.
- Support inspections from regulatory agencies e.g., FDA, HSA, EAEU (Russia), ANSM (France), COFEPRIS (Mexico), maintaining a high level of compliance throughout the organization.
- Conduct internal audits to ensure adherence to site quality standards, policies and SOPs, and internal controls are effective.
- Approve GMP documentation and site SOPs to ensure their compliance to regulatory requirements, ICH guidelines and quality standards.
Quality Assurance Specialist (Batch Release)
Pfizer Asia Manufacturing Pte Ltd
04.2019 - 07.2022
- As Lead for Batch Release team, provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Reviewed production processes and batch records and identified potential quality issues.
- Achieved timely resolution of non-conformance issues by implementing corrective action plans working closely with cross-functional departments.
- Enhanced efficiency of QA department, introducing metrics-driven performance evaluations.
- Involved in continuous improvement projects on driving continuous optimization of QA processes.
- Mentored QA specialists, fostering a culture of continuous learning and professional growth.
Quality Control Specialist
MSD International GmbH
08.2011 - 03.2019
- As a QA role, release of materials/batches based on cycle times and tight production need dates.
- Streamlined the quality control process, resulting in faster turnaround times for product releases.
- Resource planning, scheduling and execution of prioritized testing under tracking and monitoring mechanism on lab cycle and touch times.
- Reviewed production and lab scheduling and testing adherence through meetings and work out the scheduling improvements.
- Worked closely with planners, buyers, IPT and procurement teams to ensure timely releasing of batches to meet production needs.
- Worked closely with Global Procurement team to support alternate source project for identified materials.
- Revised quality control standards, methods, and procedures to meet compliance requirements.
- Participated in COMET SAP project, continuous improvement initiatives e.g. Kaizen, A3 projects, Deviations/Investigations.
- Conducted training to new Lab QA personnel.
Education
Bachelor of Science - Chemistry
National University of Singapore
01-2011
Skills
- Supplier Management
- Proficiency in SAP system
- Quality Management System
- Self motivation
- Critical thinking
- Problem-solving
- Effective communication
- Interpersonal skills
- Teamwork and collaboration
Languages
English (Fluent)
Mandarin (Fluent)
Achievements
- Certificate of Achievement issued by TUV SUD South Asia Pvt. Ltd. on Quality Management Systems ISO 9001:2015 Auditor/Lead Auditor Training Course
- Certificate for Merck Sigma Yellow Belt
- Certificate for Effective Conflict Management Programme
Professional References
Senthil Kumar
Viatris Asia Pacific Pte. Ltd. / Director of Quality
Phone: (+65) 9061 9650
Timeline
Senior Quality Assurance Specialist (Compliance)
Pfizer Asia Manufacturing Pte Ltd
08.2022 - Current
Quality Assurance Specialist (Batch Release)
Pfizer Asia Manufacturing Pte Ltd
04.2019 - 07.2022
Quality Control Specialist
MSD International GmbH
08.2011 - 03.2019
Bachelor of Science - Chemistry
National University of Singapore
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