Laboratory Systems Analyst (m/f/d)
Responsibilities
- 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
Profile
- 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
Benefits
- A highly motivated team and an open way of communication
- A very renowned company
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
- 1
- 2
- 3
- 4
1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
© Copyright Hays plc, . Das Wort HAYS, die H-Symbole, „Hays Working for your tomorrow" und „Powering the world of work" sowie damit verbundene Logos und Illustrationen sind eingetragene Markenzeichen der Hays PLC. Die H-Symbole sind Originaldesigns, die in vielen Ländern geschützt sind. Alle Rechte vorbehalten.