Philbert Sy
Qa Associate at Pharmatek
Based in San Diego, United States
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Seniority
Staff
Department
Information Technology
Location
San Diego
Industry
Pharmaceutical Manufacturing
Company size
65
Contact information
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p•••••••@pharmatek.com
Phone
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Background
About Philbert Sy
Working knowledge in Manufacturing, GMP, Quality Assurance, and GMP documentation as per FDA regulations, GMP documentation audits, and Standard Operating Procedure SOP. With more than several years of working experience in the Bio-pharmaceutical industry. Has a piece of extensive knowledge and working background on ISO 9001:2015, 21CFR 210, 210 and 811, and GMP-ICH QMS certification. Able to do root cause analysis and risk assessment for quality events (Deviations, NCMRs, OOS, OOT), Master Batch Record review and approvals, Executed Batch Record review and disposition, Material Released (API, Clinical Labels and Excipients), QA Visual Inspection (Vials, Bottling, Packaging), Room Release and Line Clearance procedures, QA Equipment Validation (IQ/OQ/PQ), Process Change Orders, SOPs, Test Methods, Manufacturing Protocols and Quality Agreements.
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