BioPharma Compliance Solutions, LLC's employees are highly-trained, experienced and dedicated to the success of our business.
John Vuong
Principle/Co-Founder
During the past 20 years Mr John Vuong has developed a very strong background in the area of setting up the GMP Manufacturing infrastructure and Quality System at Biotechnologies, Pharmaceuticals, Medical Devices, and CLIA labs. Mr Vuong brought products from conception through to commercialization. Mr Vuong improved manufacturing efficiency and reduced rework by resolving technical issues with a critical raw material. Mr Vuong had over 20 year experiences in regulated environments successfully leading groups in Manufacturing, Product Transfer, Manufacturing Technical Support, Process Development, QC, Validation, QA and RA. Mr Vuong provided comprehensive training to onsite staff regarding operational procedures, cGMP and compliance to FDA guidelines.
Mr Vuong has completed product transfers for Chiron Corporation, Novartis Corporation, Smithkline Beecham Corp, Quest Diagnostics Corp, Thermo Fishers, and Ortho Diagnostics. With Biochemistry degree Mr Vuong brings a unique technical background to the complex environment of GMP Operations.
Jeffrey, Phan
Principle/Co-Founder
Dedicated, versatile engineer with over 15 years validation experience within GMP Manufacturing infrastructure. Solid background in Lab/ Process Equipment, Utilities, Process Controls/ Manufacturing equipment, High Purity Water, Controls System, Process Cleaning, Sterilization, Dry Heat Depyrogenation, and Building HVAC/ Controls Systems qualification. Key skills include:
• Equally capable of working independently & as an adaptable team member.
• Skilled at managing, analyzing, and presenting data to a wide variety of audiences.
• Working on own initiative and quickly adapting to new projects.
• Presenting information clearly and concisely in both verbal and written form.
• Effectively collaborating in a diverse team environment.
Jeffrey is multi-lingual, and has extensive job experience with established biotechnology, pharmaceutical, and medical device manufacturing firms. He has lead several major international and local capital projects as key validation SME, from design-commissioning-validation-monitoring phases. Jeffrey’s key qualifications include:
• Extensive hands on experience in commissioning and validation.
• Experience in internal/external audit.
• Certified in deviation /CAPA as owner-investigator.
• Experience in Risk Analysis-Management.
• Experience in management of continuous improvement projects.
With an Industrial Engineering background, Jeffrey brings a unique technical background in quality engineering, commissioning, validation, and continuous improvement within a GMP environment.
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