Subject Matter Experts bringing compliance, cost and schedule certainty through well understanding of the product life cycle obtained from previous complex projects in puerto rico, USA, Mexico & Latin America including remediation projects.
Staff
• Project Managers/Leads
• Quality Assurance Specialist
• Quality Control Specialist
• Regulatory Specialist
• Inspectors/ Auditors
• Sr. Validation Specialist
• Scientist
• Validation Engineers
• CSV/ IT Validation Specialist
• Manufacturing/ QC
• Investigations & CAPA
Expertise
Strong hands-on technical and compliance expertise in:
• Regulatory Practices & Guidelines: CFR, cGMP, GxP, GLP, QSR, ISO
• Risk Management
• Start-up, Commissioning & Validation
• Manufacturing Operations
• New Products & New Method/ Technology Transfer
• Continues Process Improvements
• Training / Competencies
Solid Dosage Manufacturing
Master Plans, Start-up, Mechanical Completion, Commissioning, Equipment Qualifications, Process & Packaging Validation, Cleaning Validation, Remediation Projects, cGMP Facility Audit.
Fill & Finish/ Bulk Manufacturing
Commissioning, Utilities & Equipment Qualification, Validation, Serialization, CSV, Delta V, LIMS.
Biotech & Parenteral Manufacturing
Turnover (TOP) Packages, Commissioning, Validation, Process Improvements, Quality Review and Approval, cGMP Facility Audit.