CMC Quality By Design Expert
Vor 3 Tagen
About the Role:
We are seeking a highly skilled CMC Quality By Design Expert to join our team at Consultys. As a key member of our team, 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 invaluable in driving our business forward.
Key Responsibilities:
* Compile Quality by Design information
* Compile CMC regulatory dossier information & PACMP protocols / reports
* Enable/direct internal department digital improvement initiatives encompassing interactive training material, global portals, project reporting tools and dashboards
* Provide project coordinator support for CMC project teams and internal department improvement and strategy/innovation initiatives
Requirements:
* 5+ years' experience in the pharmaceutical industry (plasma, recombinant molecules, cell & gene therapy) or other high technology areas (MedTech, electronics)
* Project coordination/leadership; enjoys leading teams to achieve quality results in a defined timeframe
* QbD process development, scale-up, technology transfer, process validation, CMC regulatory affairs, and / or MS&TA digital expertise with hands-on experience focused on advanced data management / data processing / data analytics in a life science area
* Experience in interpreting, visualising and communicating complex project data to facilitate collaborative decision-making driving cross-functional business outcomes
* Knowledge of regulatory activities and trends, experience with health authority, i.e., FDA, EMA, PDMA, is a definite plus
* English spoken & excellent writing skills required
* German spoken & written is an asset
About Us:
Consultys is a leading company in the pharmaceutical industry, and we are committed to delivering high-quality products and services to our clients. We are looking for talented individuals who share our vision and values to join our team.
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