Vacancy expired!
- Assess existing Design History File and Risk Management file to identify gaps or areas for improvement
- Collaborate with internal functions (Pharmaceutical Sciences, Supply Chain, Pharmacovigilance) and contract manufacturers to gather and/or create deliverables for Design History Files and Risk Management Files
- Revise SOPs governing combination product processes such as Design Control, Risk Management, Device Usability as necessary
- Revise and establish procedures to comply with global GMP requirements for introduction of device/combination products to ex-US regions
- Prepare change control documentation to assess the impact of changes on existing Design History Files and Risk Management Files
- Review and approve Product Quality Complaint (PQC) investigations in electronic management system (Veeva)
- Evaluate and test returned Product Quality Complaint samples
- Identify and escalate compliance issues to Senior Management
- Bachelor of Science degree
- 5 + years of relevant GMP experience
- Solid understanding of US and international regulatory requirements and guidelines for Design Control and Risk Management
- Experience preferred in execution of key elements of Design Control (design reviews, design verification, management of design history file) and Risk Analysis processes (design, process and use FMEAs.)
Vacancy expired!