Michael Bray

About Michael Bray

I am a senior pharmaceutical Analytical/Quality Assurance consultant with over 35 years…

Experience

1. Senior Quality and Analytical Consultant Analytical Services

   Dsi - Ds Inpharmatics, A Plg Company

   Aug 2021 — Present

   Support audit programs, including Moc PAIs, and GMP audits of the manufacturing, filling, packaging processes, and functional systems, and develops solutions to mitigate identified gaps.• Quality and scientific review of documents such as EBRs, validations, specifications, methods and method transfer, stability data and reports, OOS/OOT investigations, and complaints.• Oversees the manufacturing and packaging activities and execution of the quality systems to support the manufacturing, testing, packaging, and labeling of finished products.• Performs audits/reviews of manufacturing and packaging batch records ensuring data integrity, processes align with regulations, client’s SOPs, and cGMPs.• Generate, revise, and review SOPs, policies, forms, and templates and approve investigations and CAPAs.

Education

• East Central University

  Bachelor of Science, Chemistry

  1976 — 1979

Skills

• Computer System Validation
• Dissolution
• Technology Transfer
• Cleaning Validation
• Validation
• Project Management
• Process Improvement
• Quality Control
• Gmp
• Quality Assurance
• Analytical Chemistry
• Pharmaceutics
• Gxp
• Quality Auditing
• Aseptic Processing
• Chemistry
• Technical Writing
• Pharmaceutical Industry
• Sop
• Fda
• Cross-Functional Team Leadership
• 21 Cfr Part 11
• Laboratory
• Supply Chain
• Software Documentation
• Regulatory Requirements
• Quality System
• V&V
• Manufacturing
• Capa
• Glp
• Change Control
• Lims