Quality Assurance Specialist

Home office & hybrid working

We do have a hybrid work model. The candidate is expecting to be at a minimum of 3 days per week and might increase depending on business needs.

The Global Development Quality OPS team is responsible for driving or supporting compliance-based programs and results, which include support cross functional projects, solving simple problems, current Good Manufacturing Practices (cGMP) quality initiatives, quality system improvements, quality directives, compliance metrics and monitoring, SOP management, and site procedures at the company's production site.

• Participate in the release or rejection of GMP materials and components either through direct batch release support or involvement with critical program issues.
• Perform documentation, system or any other GMP record review in relation to the QOS activities.
• Conduct all work meeting high standards for quantity, integrity, quality, and GMP compliance.

• Previous experience in a similar role is highly appreciated; a university degree (bachelor or higher) is preferred; experience in a regulated environment is an advantage.
• Language requirements German C1 mandatory, English business proficient is highly preferred.

3 time per week the day starts at 8:30 with a team meeting to discuss ongoing activities. During the day, the person will work on records review.