Director of Quality Assurance Operations & Compliance at Pii (Pharmaceutics International, Inc.).
Industry
Medical / Health Care / Pharmaceuticals
About
Twenty four years of professional experience in Pharmaceutical/Biotech Industry with extensive knowledge in Quality Assurance, Quality Control, Validation, Tech Transfer, Compliance, Regulatory Affairs and Regulatory Inspections for commercial products
Comprehensive knowledge of "Quality Management Systems" including investigations with root cause analysis and CAPA (Corrective Action Preventive Action), Batch release, Change Control, Analytical methods/assay development, Statistical analysis and QC testing
Specialties: Manufacturing & Operations
Strategic & Operational Planning
Team Development & Leadership
Metrics & Status Reporting
Project Planning & Management
Customer & Partner...
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