Senior QC Specialist - temporary

Are you an Analytical Expert who can demonstrate creativity in the field of analytical science and technology and with an interest in analytical lifecycle management.? We are looking for an expert who can support not only our current and but also future analytical control strategies for new chemical entities ensuring long-term supplies to our patients. We play a meaningful role in the late phase delivery, launch and lifecycle management of small molecule drug substances.

Main responsibilities:

• Analytical expert supporting launch and lifecycle management of projects in collaboration with the analytical project lead and multiple partners
• Manage product specifications including the design, development, validation, transfer and performance monitoring of analytical procedures/technologies
• Good understanding of scientific, regulatory and quality standards
• Ensure training according to cGMP requirements
• Maintain excellent planning and collaboration with internal and external stakeholders (e.g. laboratory analysts, production specialists, manufacturing science and technology, quality assurance, regulatory CMC, project leaders, colleagues and third parties)
• Design and plan analytical experiments. Interpret and report results in preparation for timely delivery of project milestones
• Support change control, preparation of the regulatory dossier and health authority inspections
• Support root cause investigations (deviations / OOX)

Languages :

• German
• English.