Arrowhead Pharmaceuticals needs to ensure compliance with cGMP, GLP, and GCP regulations for computerized systems, software, and IT infrastructure.
Requirements
- Working knowledge of overall GMP and/or GLP FDA, EU, and ICH regulations
- Prior experience with use of an electronic document management system in a regulated environment (preferred)
- Knowledge of computerized system, equipment, and/or instrument qualification
- Knowledge of CSV processes and regulations
- Knowledge of data integrity requirements
- Knowledge of risk assessments and mitigation strategies
- Knowledge of validation documentation and testing protocols
Responsibilities
- Provides Quality guidance for CSV efforts related to requirements engineering, system risk assessments, and data integrity assessments.
- Reviews and approves validation documentation, including Validation Plans, Requirements Specifications, Risk Assessments, Functional Requirements Specifications, Testing Protocols, Requirements Trace Matrices, and Summary Reports
- Serve as an SME for CSV and maintain knowledge and information in the Computer System Validation area of expertise
- Review CSV documentation to ensure data integrity requirements are maintained
- Review and approve discrepancies / deviations encountered during qualification / validation activities
- Review, assess, and approve computerized system change controls
- Coordinate validation activities with key stakeholders
Other
- Bachelor’s degree in an applicable science field
- Additional Quality related certification desired, CQA, CQMP
- Minimum of 5 years of experience in a pharmaceutical/biotech company, contract manufacturing organization, or contract research organization
- Authorization to work in the US for a company
- Ability to communicate CSV approach in support of audits
- Ability to prepare documentation and provide support for regulatory inspections and inspection readiness activities
