John Chiu

Background

About John Chiu

Detail and results-oriented Senior Quality Assurance Engineer with 18 years of extensive solid dosage pharmaceutical manufacturing quality systems experience (~6.5 billion tablets/240+ packaging SKUs annually). Sound understanding of cGMP for FDA and ANVISA requirements for generic and brand combination, DEA controlled (Schedule I-IV) and hormonal drugs. Experienced with consent decree remediation, product transfers, regulatory inspections and site closure management. Recognized as a proactive, effective and motivational team player with a consistent track record in delivering bottom-line results and streamlining systems to improve and increase department productivity, quality, and efficiency. Key competency:• Quality Assurance• cGMP Compliance• Investigations• Root Cause Analysis• Technical Writing• TrackWise• Part 11 Compliance• Change Control• Supplier quality projects• Process improvement • Validation life cycle• Project Management• FDA and DEA Audit Experience• Pharmaceutical Labeling• GMP Training and Coaching• Pharmaceutical Packaging