Singapore
Core Experience: -> Management of supplier quality - relationship and performance -> Packaging Material manufacturing (plastic bottles, caps, laminated foils) -> API and Raw Material manufacturing -> Business partnering with procurement on strategic supplier selection, negotiation & management -> Microbiology (Laboratory Operations, Method Development & Validation, Risk Assessment) -> Non-sterile, Primary API manufacturing -> Familiar with Regulatory Guidelines (USP, EP, EMEA, ICHQ7, ICHQ6) -> Auditing experience (internal audit and external service proivider)
Core role: Microbiology support of outsourced material Microbial Method transfer Microbial troubleshooting in the plant Microbial Risk assessment Additional role: Management of Analytical Equipment Analytical Equipment Validation (GC headspace, TOC, IR, RAMAN, UV, SSA)
Technology Transfer of New Product (Microbiology Lead) Microbiology Laboratory Operations Expertise in: - Microbial Identification, - Water System Monitoring & Validation (6 systems) Operational Excellence Advocate Program
- Team leader of Microbiology Laboratory (supervised 2 QO Analyst) - General Routine Duties: inventory/stock management, equipment maintenance, media preparation, positive control and growth promotion testing, autoclave maintenance (Annual temperature profile/ biological indicator checks) - Purified Water sampling and testing. - Final Product (API) testing: Detection of pathogen - culture maintenance. - Perform bacterial Endotoxin test on water and API final products (by gel clot method). - Validated bacteria identification system, VITEK32
- Water sampling and testing - Microbiological analysis of end product and environmental samples - Use of VIDAS machine to test for Salmonella and Listeria - Fat and moisture analysis of products