Renjee Andrada

• Lead quality initiatives to address system inefficiencies by implementing and managing quality programs, tracking performance, analyzing data, reporting findings, and driving problem-solving efforts to achieve continuous quality improvement
• Support organizational goals and ensure compliance with company policies, quality systems, and relevant regulations, including cGMP, FDA guidelines, and other industry standards
• Ensure adherence to international standards such as ISO 9001, ISO 14001, ISO 13485, ISO 14971, and FDA 21CFR Part 820 by maintaining and improving systems and procedures
• Serve as Supplier Quality Engineer for inter-company purchased raw materials, ensuring compliance with quality specifications and driving supplier performance improvements
• Contribute to Product Qualification activities, reviewing test protocols and reports to ensure product quality meets specified requirements and regulatory standards

Achievements:

• Implemented a streamlined Damage Handling Process at the Asia Distribution Centre, reducing turn-around time from 30 days to an average of 5 days. This initiative also enhanced disposition accuracy by 80%, significantly minimizing the Cost of Poor Quality (COPQ) and achieving substantial recovery savings through effective product salvaging efforts, returning items to prime condition.
• Developed and implemented the Cold Shipment Return Process, a protocol for managing the return of temperature-sensitive (cold chain) shipments to the Asia Distribution Centre. This process ensured proper documentation, safe transport, and compliance with regulatory and quality standards. Successfully monitored 10 returned shipments between 11-Nov-2024 and 12-Dec-2024, achieving 100% timely disposition and safeguarding product quality and compliance.
• Co-developed and implemented the Inter-DC Damage Return Process to efficiently manage the return of damaged goods between Distribution Centers (DCs) and manufacturing facilities. This initiative ensured proper logging, corrective action planning, and loss minimization while maintaining operational efficiency. Collaborated closely with Singapore-based planners and return administrators to establish a streamlined process for managing the return of SG-manufactured instruments from overseas DCs back to manufacturing in Singapore, enhancing product recovery and reducing turnaround times.

• Monitor operations in real time through Advanced QCC (AQCC), ensuring updates across systems
• Identify and resolve exceptions using diagnostic processes to address potential issues
• Implement contingency plans to ensure smooth operations during disruptions
• Respond to network requests promptly and accurately, ensuring efficient communication
• Generate service incident reports in a timely manner for transparency and accountability
• Escalate unresolved cases to the Regional SQ/QCC team as per SLA
• Produce and analyze HUB reports, including recap and inbound volume reports, to track performance

• Monitor shipments in real-time to proactively identify potential failures and disruptions
• Diagnose root causes of issues using established processes and collaborate with the Network to resolve roadblocks
• Escalate unresolved issues to the QCC Head promptly for further action and resolution
• Review service failure cases with the QCC Head to identify recurring issues and drive corrective actions
• Communicate internal gaps in the QCC monitoring system to the QCC Head for remedial action at the end of each shift
• Support development initiatives, including new country QCC set-ups, project participation, and training delivery

• Lead Quality Operations for Singapore and Malaysia, overseeing the Quality System, Food Safety/HACCP, ISO Manual, Cold Chain Manual, and GMP Working Instructions
• Conduct internal assessments to ensure the Quality System complies with relevant standards
• Manage the Corrective & Preventive Action Program, handling complaints, non-conforming materials, document control, and quality control inspections
• Oversee external assessments of the company's Quality System by external assessors
• Serve as Management Representative for ISO 9001:2008 & ISO 22000/FSMS, authorized to create, maintain, and modify the Quality System
• Review and approve supplier components, raw materials, products, and services to ensure compliance with quality standards
• Assist in certification and assessment of critical suppliers and maintain the Approved Supplier List
• Liaise with 3rd Party Auditors (e.g., MBS, KFC, 7-Eleven, Government, and Private Customers) for Food Safety and worker safety audits and compliance
• Act as QMS Document Controller, managing the Quality Management System and Food Safety/HACCP/ISO document control systems
• Ensure quality record legibility and maintenance for compliance
• Provide documentation to regulatory agencies and customers as required

• Food Safety (GMP-SSOP,HACCP, ISO 9001:2008, ISO 22000/FSMS) Systems implementation and management
• Production Operations Safety - Compliant to Government Rules & Regulations
• Logistics Management
• Operational Strategizing
• Management of Support Services
• Management of Third Party Relations
• Inventory Management
• Construction of Operations and Food Safety Manual
• Implementation and close monitoring of guidelines pertaining to Operational and Food Safety requirement
• Setting-up of quality system and sustainable operations

• Assist QA Manager in implementing HACCP/GMP-SSOP systems across operations to ensure food safety and personnel safety
• Monitor product contact areas to ensure food safety standards are met
• Oversee personnel safety by monitoring common areas where clients and staff work
• Complete forms/checklists to verify safety of water, ice, personnel, and general food safety
• Document non-conformances by filling out Notice of Unusual Occurrence Reports during inspections
• Conduct regular GMP-SSOP (HACCP) seminars to reinforce food safety protocols
• Support visitors, auditors, and investors, both local and foreign, by providing relevant information and assistance
• Attend seminars and conferences to stay informed and contribute to decision-making for enhancing the food safety system