Specialist Operational Quality Assurance - Digitalization
Mainz, Germany | full time | Job ID:8605
As a Specialist Operational Quality Assurance - Digitalization, you will be responsible for the digitalization of GMP relevant data on a risk-based approach, setting up automated information workflows, and identifying data that requires digitalization. You will work closely with the Manager Operational Quality Assurance - Digitalization (all genders) and support them in their responsibilities within the company and towards authorities and sponsors.
Digitalize GMP relevant data on a risk-based approach
Identify data which requires digitalization
Setup automated information workflows and applications
Support the Manager Operational Quality Assurance - Digitalization (all genders) in representing QA topics in the field of work towards authorities and sponsors
Provide preparation und support for routine reporting into quality management
University degree or proven equivalent experience in computer science, data science/engineering, information systems, big data management or AI science/engineering
Experience in digital transformation of business processes, ideally in the GMP environment
First Experience with AI and Large Language Models and programming skills
Knowledge of tools and technologies used for automating workflows and processes (e.g. MS Power Platform)
Understanding of data management practices and standards (e.g. data architecture, data quality, metadata management)
Experience in collaborating with interdisciplinary teams and representing QA topics to internal and external stakeholders
Knowledge of statistical methods and analysis tools for data analysis and evaluation
Quality mindset and knowledge of EU GMP and FDA regulations and FAIR and ALCOA+ principles
Strong communication and presentation skills in both German and English
Team spirit and collaborating skills
It's our priority to support you:
Your flexibility: flexible hours | vacation account
Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
Your health and lifestyle: Company bike
Your mobility: Job ticket | Deutschlandticket
Your life phases: Employer-funded pension | Childcare