Diana, Jie Yi Ong

• Communicate identified compliance and quality risks to supervisors for resolution.
• Conduct regular assessments of Quality Systems (E.g. process inspections, facility inspections, equipment record reviews and computer system validation activities
• Analyze and review client audit observations to ensure alignment with internal practices and regulatory standards.
• Review SOPs, batch records and other regulated records, including deviations, change controls, and Corrective and Preventive Actions (CAPA), to ensure accuracy and regulatory compliance.
• Offer insights and recommendations for enhancing audit practices, process compliance, and overall quality assurance efforts.
• Prepare study and QA files ahead of sponsor site visits and regulatory inspections.
• Assist in supporting client site visits and ensuring regulatory requirements are met.
• Participate in training staff on compliance with applicable regulations (ISO/GLP/GMP).
• Assist in the collection of site Quality Metrics, support preparation for QMR meetings, and help analyze metric data for continuous improvement.
• Provide timely responses to customer inquiries related to regulatory qualifications and requests.
• Perform any other related duties that help support compliance, quality assurance, and regulatory functions within the organization.

•Performed routine analytical testing (Endotoxin) and (ELISA) in accordance to SOP adhering to ALCOA principles and Data Integrity (DI) requirements.

•Executing daily work with usage of Laboratory Systems such as SAP and LES (Systems Applications and Products in Data Processing, Laboratory Execution System).
•Participated in MAPS24-V Project demonstrating ability to work collaboratively and effectively with other departments while managing time efficiently in order to complete all tasks within deadlines.

•Initiate and participate in laboratory investigation (OOS / deviations / atypical results invalid results) and assist in timely closure of investigation and CAPA.
•Participated in method validation (Method Suitability).
•Support in Laboratory operations (calibration and maintenance, reagent/buffer preparation, chemicals/ consumables inventory).

•Cultivated interpersonal skills by building positive relationships with others.

• Adhering to company SOP and ISO standard 9001 to fill meticulously of calibration gas mixtures with multiple components, gaseous chemical, LPG and liquid mixtures in accordance specifications in form of different sizes of cylinder
• Support in documentation and records for audit purposes
• Regular involvement in company safety initiatives such as BSV participation and submission of near misses
• Monthly involvement & inspection of 5s findings
• Troubleshooting & maintenance of filling systems & manifolds when needed
• Collaborate and liaising with Laboratory on new product

• Assisting in preparation of bench top experimental set up for day & night classes
• Responsible for observing all laboratory work was conducted in accordance with SOPs and GLPs
• Maintaining and calibrating of Lab equipment
• Weekly update on Lab Inventory
• Performed administrative duties and staff support tasks.

• Perform surface preparation & coating application on vessels, pipes and tanks.
• Perform Quality Check on painted items using Bresle Chloride Kit, Coating Thickness Gauge to ensure items is within the required spec before delivering to customers.

• Maintained high customer service standard and provided various form of assistance at all time
• Operated cash register (POS) and credit card machine
• Maintained a clean and go workspace in accordance to hygiene policy and standards
• Conducted in-house training for new hired part-timers to educate them on shop operation and products
• Possess good knowledge and understanding of menus and be willing to recommend customers on how to make their choices from menu
• Maintained energy and enthusiasm in fast-paced environment.
• Offered friendly and efficient service to customers, handled challenging situations with ease.
• Maintained excellent attendance record, consistently arriving to work on time.