Quality

• Quality systems establishment and evaluation
• Quality systems revision/upgrade
• Risk assessment and developing quality risk management systems
• Risk management/planning
• Compliance assessment for GLP, GMP and GCP
• Pre-inspection readiness audits
• Preparation for pre-approval inspections (PAI)
• Establishing quality assurance and quality control functions
• Knowledge and application of standards e.g. ASTM and ISO
• Training
• Facility assessment
• Quality investigations
• Risk assessment and developing quality risk management systems
• Risk management/planning
• Product development reports
• Perform audits and inspections (US and global)
• Author Drug Master Files
• Develop Validation Master Plans
• Change control development (pre- and post-approval)