Job
- Level
- Experienced
- Job Field
- Test/QA
- Employment Type
- Full Time
- Contract Type
- Permanent employment
- Location
- Biberach an der Riß
- Working Model
- Onsite
Job Summary
In this role, you lead the planning and implementation of study-specific IRT concepts, develop new solutions to ensure compliance with GMP and GCP, and support the validation of computerized systems.
Your role in the team
- Management of activities such as assessment, planning, conceptual implementation, and deployment of study-specific IRT concepts.
- Representation as IRT contact person in cross-departmental study and project teams.
- Further development of IRT concepts through new approaches and solutions.
- Ensuring compliance with GMP, GCP, and international guidelines with a focus on patient safety.
- Additional tasks for the Expert role: Support of activities for the validation of computer-based systems.
This text has been machine translated. Show original
Our expectations of you
Education
- Completed scientific master's degree or completed bachelor's degree with experience in a related field or quality environment.
Qualifications
- Understanding of the software development cycle, including validation of cloud systems.
- Knowledge of regulatory requirements as well as GMP/GCP regulations in the pharmaceutical industry.
- Knowledge of global audit activities as well as the conduct and design of clinical trials.
- Excellent communication skills as well as fluent written and spoken English.
Experience
- Experience in the IRT field as well as knowledge of the technical aspects of IRT systems.
This text has been machine translated. Show original
Benefits
More net
Health, Fitness & Fun
Work-Life-Integration
Topics that you deal with on the job
Job Locations
This is your employer
FERCHAU Engineering GmbH
Description
- Company Size
- 250+ Employees
- Company Type
- Recruiting Agency
- Working Model
- Full Remote, Hybrid, Onsite
- Industry
- Recruitment Agency
IRT Specialist / IRT Expert
- Location
- Biberach an der Riß
- Working Model
- Onsite
- Diversity
- Open for all genders
