Patricia Davis

About Patricia Davis

Senior Quality Assurance professional with Analytical Chemist background and extensive global and leadership experience. High level technical and quality principles expertise in Pharmaceuticals industry. Extensive knowledge of manufacturing, packaging, warehousing of commercial and clinical product. Experience in small molecule, biotech, API and aseptic processing and GMP compliance. Also skilled in analytical testing and training. • Investigations and CAPA• Internal and External Audits• Validation and Qualification• Change Control• Regulatory Inspection Support• Batch record review• SOP author and approver• Merger facilitation and harmonization • Decommissioning procedures

Experience

1. External Quality Principle Technical Manager

   Genentech

   Aug 2016 — Present

Education

• State University of New York at Delhi

  AAS, Veterinary Science

• Thomas Edison State University

  Bachelor's degree, Natural Sciences and Math

• Rutgers University

  Mini-MBA, BioPharma Innovation

Skills

• Quality Assurance
• Biotechnology
• Six Sigma
• Gxp
• Quality Auditing
• Aseptic Processing
• High-Performance Liquid Chromatography (Hplc)
• Quality Control
• Gmp
• Validation
• Glp
• Sterilization
• Regulatory Affairs
• Lifesciences
• Capa
• Vaccines
• Computer System Validation
• CRO
• Pharmaceutical Industry
• Sop
• Fda
• Manufacturing
• Technology Transfer
• Laboratory
• Drug Development
• Lims
• Gcp
• Biopharmaceuticals
• Clinical Trials
• Pharmaceutics
• Quality System
• V&V
• Regulatory Submissions
• Regulatory Requirements
• Ind
• 21 Cfr Part 11
• Hplc
• Clinical Development
• Change Control
• Cleaning Validation