Laboratory Systems Analyst (m/f/d)
- Assess laboratory instruments and software for their compliance with Data Integrity guidelines
- Implement Data Audit Trail Reviews for laboratory instruments and software
- Create documentation in English and German for qualification, validation and lifecycle management of existing and newly implemented laboratory automation systems, analytical instruments, and software applications in collaboration with Engineering and I&T departments
- Manage local and global qualification and validation projects
- Collaborate with internal and external stakeholders within qualification and validation projects for technical requirement specifications, data integrity, and automation activities
- Support the update of procedures related to laboratory instrumentation and computerized systems (i.e., USP, 21CFR Part 11, Annex 11 regulations) to ensure compliance with guidelines and industry best practices, as well as harmonization within the global organization
- University degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, Bioinformatics, Computer Science, etc.)
- Solid experience in a pharmaceutical/medicinal GMP testing environment using a variety of testing instrumentation, with experience in equipment qualification or CSV and lifecycle activities
- First project management experience in an operational environment
- Knowledge of regulations on computerized systems and laboratory automation, and a willingness to extend skills and know-how in the field
- Strong written and verbal communication skills in German and English, both oral and written, to ensure effective collaboration with cross-functional teams both locally and globally
- Strong analytical/problem-solving skills, technical IT affinity, and organizational skills
- Ability to work independently and as a team member in a high-performance environment
- A highly motivated team and an open way of communication
- A very renowned company
Über die Firma
