Dr. Kevin Siver, PhD, Onyx Pharmaceuticals10.01.14
Inherent Responsibilities:
Market Authorization Holder
•Product Specs
•Stability Protocol
•Analytical Methods
•Process Validation
•Critical to Quality Attributes
•In-Process Controls
•Source/Quality of raw materials
•Quality Management System
Contract Manufacturer
•Facilities Design
•Equipment Qualification
•Instrument Qualification
•Pest Control
•HVAC
•EHS
•Oversight of suppliers
•Quality Management System
Market Authorization Holder
•Product Specs
•Stability Protocol
•Analytical Methods
•Process Validation
•Critical to Quality Attributes
•In-Process Controls
•Source/Quality of raw materials
•Quality Management System
Contract Manufacturer
•Facilities Design
•Equipment Qualification
•Instrument Qualification
•Pest Control
•HVAC
•EHS
•Oversight of suppliers
•Quality Management System