Employees ITOT Compliance
vor 2 Monaten
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
Completed studies/university of applied sciences in medical technology, chemistry, biology, biotechnology or comparable training with several years of professional experience Experience in the diagnostics/research market German language skills, business fluent English (B-Level), other foreign languages an advantage Structured, independent way of working GMP and regulatory knowledge Knowledge of statistics, databases, graphics, word processing and technical documentation Understanding of the laboratory environment and product application
Your tasks
Creation, processing, follow-up and closure of changes, deviations, corrections and preventive measures 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) Creation and processing of risk analyses in the quality risk management environment Ensuring operational GMP-relevant documentation (e.g. records management) or the creation and processing of regulations (e.g. content management) in the automation environment Preparation, support and follow-up of audits and inspections Representation of the unit with regard to QA and training topics, as well as the implementation and organization of training in the unit Supporting validation and qualification projects and participating in the establishment of new IT & automation systems
Your profile
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 4-6 years of professional experience after graduation Experience in quality assurance Experience in a GMP environment is an advantage Experience as (partial) project manager or in-depth knowledge of automation technology or complex IT systems Knowledge of pharmaceutical manufacturing and software development processes Specialized knowledge and limited management tasks or responsibility for sub-areas, ongoing activities, targets and product portfolios Meticulous way of working Fluent German and good English skills-
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