Enter the world of innovation and cutting-edge research in a leading international company.
Our dynamic team in the heart of picturesque Penzberg sets new standards in the development of pioneering medical solutions. We offer ambitious talents the opportunity to contribute and develop their expertise as an ITOT Compliance employee .
Here's what we offer
1. Completed studies/university of applied sciences in medical technology, chemistry, biology, biotechnology or comparable training with several years of professional experience
2. Experience in the diagnostics/research market
3. German language skills, business fluent English (B-Level), other foreign languages an advantage
4. Structured, independent way of working
5. GMP and regulatory knowledge
6. Knowledge of statistics, databases, graphics, word processing and technical documentation
7. Understanding of the laboratory environment and product application
Your tasks
8. Creation, processing, follow-up and closure of changes, deviations, corrections and preventive measures
9. Performing quality assurance tasks for the unit's QA, IT and automation systems, including associated processes (e.g. archiving, maintenance of master data and maintenance contracts, data integrity)
10. Creation and processing of risk analyses in the quality risk management environment
11. Ensuring operational GMP-relevant documentation (e.g. records management) or the creation and processing of regulations (e.g. content management) in the automation environment
12. Preparation, support and follow-up of audits and inspections
13. Representation of the unit with regard to QA and training topics, as well as the implementation and organization of training in the unit
14. Supporting validation and qualification projects and participating in the establishment of new IT & automation systems
Your profile
15. Bachelor, Master, Diploma, e.g. chemical engineer, biotechnology engineer, university degree in computer science, chemistry, biology, biotechnology, process engineering or equivalent technical training with practical experience
16. 4-6 years of professional experience after graduation
17. Experience in quality assurance
18. Experience in a GMP environment is an advantage
19. Experience as (partial) project manager or in-depth knowledge of automation technology or complex IT systems
20. Knowledge of pharmaceutical manufacturing and software development processes
21. Specialized knowledge and limited management tasks or responsibility for sub-areas, ongoing activities, targets and product portfolios
22. Meticulous way of working
23. Fluent German and good English skills