Beschreibung
Description:Initiation and supervision of qualification processes of complex analytical systems including the corresponding software qualification. Responsible for the high quality / data integrity of qualification processes, SME-in the related fields. Participator/leader of global harmonized continuous improvement projects. Writing and reviewing of relevant SOPs in compliance with given guidelines.
Ideal Background (state the required education and experience levels)
- Education (minimum): Technical expert studies with PhD and 0-2 years relevant experience
- Master of Science with 4 years of relevant experience
- Bachelor of Science or equivalent technical education with 8 years relevant experience in industry or equivalent
- Fluent in English (oral and written)
- Basic skills in local site-language (German), as required for the position & Awareness of safety regulations and for safe handling of chemicals and equipment.
- Appropriate number of years of experience in an analytical GMP environment.
- Very good knowledge of qualification processes for laboratory systems in a GMP environment including software qualification (CSV) and related technical tools and software.
- Scientific project management and leadership skills
- Good knowledge on relevant regulatory guidelines and good understanding of regulatory expectations
- Very good with laboratory and/or technical tools. Ability to work in and lead teams.
- Good knowledge of software and computer tools.
- Good documentation skills and Good presentation skills
- Very good communication skills