Quality Improvement Project Specialist (R&D) İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
Job Description
- Project Lead for FDA Inspection Readiness Project
- Key contact for R&D Product Development and Analytical Method Development project groups
- Key contact for Consultants. Planning & Follow Up of consultancy programme.
- Lead all activities related gap analysis and capa follow up
- Coordinate all project related activities according the needs and priorities
- Organize routine follow up meetings with SMEs to monitoring of the actions
- Periodic reporting about project status
- Support to SMEs for their development programme
Qualifications
- Bachelor’s degree required in a field such as Chemistry, Biology, Pharmacy or equivalent
- Strong understanding of R&D operations and Quality By Design
- FDA Inspection experience
- Excellent research and analysis skills especially in terms of understanding US FDA inspection policies and requirements
- Experience reading and interpreting FDA regulations and sub-regulatory guidance
- Advanced Project Management skills combined with a structured and solution-oriented work approach
- Capable of working collaboratively in a team environment
- Strong personal integrity, patience, discretion, and maturity
- Strong Leadership and Stakeholder management skills
- Experienced with Quality Systems (GMP)
- Excellent communication skills and interaction with all kinds of internal and external interfaces
- Fluency in English,
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