CMC Quality By Design Expert
Vor 6 Tagen
As a CMC Quality By Design Consultant at Consultys, you will be responsible for leading small expert teams to compile quality by design and regulatory dossier information. Your expertise in QbD process development, scale-up, technology transfer, process validation, and CMC regulatory affairs will be essential in driving quality results in a defined timeframe.
Key Responsibilities
- Compile quality by design information and CMC regulatory dossier information
- Enable and direct internal department digital improvement initiatives
- Provide project coordinator support for CMC project teams
Requirements
- 5+ years' experience in the pharmaceutical industry or other high technology areas
- Project coordination/leadership experience
- QbD process development, scale-up, technology transfer, process validation, and CMC regulatory affairs expertise
- Excellent writing and communication skills
Preferred Qualifications
- Knowledge of regulatory activities and trends
- Experience with health authorities such as FDA, EMA, and PDMA
- German spoken and written skills
About Consultys
Consultys is a leading consulting firm in the pharmaceutical industry, providing expert services in quality by design, regulatory affairs, and digital transformation. We are committed to delivering high-quality results and driving innovation in the industry.
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