Notable Achievements:✨ Spearheaded the Quality Department, implementing a robust Quality Management System for ISO 15189/HCSA/LDT/HBRA/HTF. ✨ Commended for high QMS standards, outstanding audit preparation, and minimal findings.✨ Led a cross-functional team to maintain regulatory compliance.✨ Well-Being First Responder, promoting mental health and well-being in the workplace. ✨Acted as BCP Coordinator, ensuring business continuity planning and resilience. Driving Excellence in Preclinical & Clinical Services:🧪 Quality Maverick: Ensured top-tier compliance across preclinical and clinical services.🧪 Precision Auditor: Achieved flawless audits and unblemished compliance.🧪 Training Innovator: Pioneered cutting-edge training programs in quality management.🧪 Safety & Data Guardian: Implemented robust safety and data protection protocols.🧪 Problem Solver: Engineered solutions to complex quality issues.🧪 Culture Builder: Fostered a culture of quality excellence.🧪 Excellence Achiever: Received accolades for exemplary quality management reporting.

🐁 Quality Revolution: Transformed preclinical services and consumables units with a gold-standard quality management system for ISO 17025. 🐁 Precision Architect: Designed meticulous assay requirements and bespoke SOPs, ensuring alignment with industry norms.🐁 Excellence Guardian: Developed tools for continuous quality assessment and rapid issue resolution.🐁 Problem Solver: Investigated and resolved complex quality issues with effective solutions.🐁 Culture Champion: Promoted a culture of quality improvement and innovation.🐁 Training Innovator: Delivered cutting-edge training programs in quality management techniques.

1. Enforcing the highest quality standards in an HSA accredited cGMP cleanroom with a focus on Environmental Monitoring (EM):-Conducting sampling as per SOP frequency and generating microbial trending data (viable and non-viable, water).-Validating methods of analysis and ensuring compliance with cGMP standards.-Managing third-party laboratories, including calibration, scheduling, and generating reports and quotations.-Reconciling Biological Indicators (BI) and media plates.-Conducting, tracking, and trending gowning qualification/re-qualification for personnel entering the cleanroom.2. Raw Materials Release:-Validating new materials and qualifying/re-qualifying suppliers.-Reviewing raw material SOPs and relevant certificates.-Creating SOPs for new materials and updating the master list.-Releasing incoming raw materials, consumables, and components in the SAP system.3. Finished Product Management:-Facilitating shipment and ensuring re-tests are conducted for required samples.-Developing methods of analysis, sampling plans, and specifications for final products.-Reviewing MSAT raw data and QC test results, compiling results for final product testing.4. Internal and External Audits:-Auditing external contract laboratories for compliance with ISO 17025, PIC/S guidelines, USP, FDA CFR 21 Part 11, FDA GLP and GMP, EU Annexes 1, ISO 14644, and ISO 9001.-Participating in and managing HSA CTGTP audits, serving as a runner for audits.-Participating in and managing internal and customer audits.5. Documentation and Continuous Improvement:-Creating and maintaining documentation for Quality Control.-Tracking training statuses for the team and personal development.-Collaborating with cross-functional teams to ensure the success of batch releases, dispositions, and New Product Introductions (NPI).-Initiating and closing change controls, Corrective and Preventive Actions (CAPA), and deviations by performing root cause analysis.

Enforce highest standard of all products through stringent microbiology tests with aseptic technique like:· Bioburden test· Sterility test using Liquid broth B and Equinox Steritest· Bacteria Identification using gram stain· Growth Promotion test using pour plate and streak plate method· Bacteria SubcultureSupported microbiology lab’s daily operations like:· Media preparation for bacteria and fungi/mold testing· Decontamination of plates/media after testing is completed by autoclaving· Conducted routine environment monitoring for cleanroom environment for production and lab (air and water sampling)· Compiling and analyzing microbiological data for products and board meeting· Validation of autoclave sanitation using biological indicator· Washing of glassware and apparatus after testingQuality oriented overall in-charge of microbiology lab daily operations.(Schedule and manpower planning, purchasing/planning/control of inventory, testing for product registration in various countries, stability studies, engineering studies, coordinate and arrange external testing and etc.)Developed and revised most of the protocols and procedures for micro-lab to comply with requirements (ISO, FDA, EU, Pharmacopoeia, GMP, GLP, GDP and etc.).Apprehensive leadership and analytical skills by leading other departments for detailed root cause investigation and analysis, as well as corrective and preventive actions for any deviations and/or out of specifications.Created and conducted many engineering studies for micro-lab to support various innovative cost reduction initiatives.Readiness in the lab was always ensured for internal, external/regulatory and customer audits.Numerous training was planned and conducted across the company and in the lab.All work place safety and health concerns were mitigated by working closely with management as a WSH committee.

Executed and achieved numerous audit certifications as management representative (ISO 22000, ISO 45000, BIZSAFE STAR, HALAL, OHSAS, SS 506, NEA Cleanmark). Implemented and ensure good hygiene standard in all 4 facilities with swab tests and scheduling routine cleaning. Customer oriented service and quality provider in our products to the highest and most stringent standards, inclusive of resolving complains with root-cause analysis. Creative and driven, who has many ideas and plans to drive continuous improvement in all facilities by leading a team of 15 professionals. Patient and well versed in various trainings for all staffs (approximate 180 staffs) with routine test conducted for monitoring purposes.