Vacancy expired!
- Real-time Inspection Readiness
- Manage Inspection Readiness Plans associated with regulatory filings
- Work with internal teams on key issues to ensure inspection readiness
- Understand timelines and interdependencies
- Assist with developing and providing oversight of mitigation plans
- Communicate risks
- Utilization of tools to ensure efficiency in execution
- Assist in maintenance of opening presentation, Site Master File, SME list and storyboards
- Manage Inspection Readiness Plans associated with regulatory filings
- Management of vendor certificates and declarations to support GMP activities
- Work with regional regulatory representatives to understand renewal schedule
- Request required documentation from CMOs / internal team
- Assist with Quality Management Review
- Maintain QLT documentation and action items
- Master's degree and 3 - 4+ years of relevant work experience, or Bachelor's degree with 6+ years of relevant work experience
- Project Management skills
- Knowledge and application of: GMP/GDP regulations and application to Manufacturing and Testing risk management principles, Root Cause Analysis tools/methodology and CAPAs, and Audit process
- Operational QA experience in analytical or manufacturing setting with experience with the following is preferred:
- inspection support roles
- Quality System background
- Interpretation and application of GMPs and applicable guidelines/guidances (e.g., ICH, USP, etc.) or other industry best practices (e.g., ISPE, WHO, etc.)
- Experience with small molecules. Experience with biologics, devices, gene therapy a plus.
- Experience with electronic document management systems (e.g., QDoccs, Veeva)
- Health insurance
- Casual Dress code
- 401k match
Vacancy expired!