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Quality Assurance Manager

vor 2 Monaten


Frankfurt am Main, Hessen, Deutschland GULP – experts united Vollzeit

**About the Role**

We are seeking a highly skilled Quality Assurance Manager to join our team at GULP – experts united. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our sterile production processes.

Key Responsibilities:

  • Support the development and implementation of quality policies and procedures in sterile production.
  • Process and investigate deviations and change controls, defining and tracking corrective actions.
  • Perform and support validation and qualification activities, creating associated documents.
  • Conduct on-site supervision of sterile production processes.
  • Prepare and revise annual product quality reviews, trend analyses, and SOPs.
  • Collaborate with cross-functional teams to define quality-relevant parameters and measuring points.
  • Process issues and projects within sterile production, adhering to cGMP guidelines.
  • Prepare and support inspections by authorities, customers, and internal departments.

Requirements:

  • Completed university degree in a relevant field, such as pharmacy, biology, microbiology, or chemistry.
  • Several years of experience in the pharmaceutical industry, preferably in quality assurance, quality control, or production.
  • Knowledge of national and international GMP regulations, including EU and FDA guidelines.
  • Excellent written and spoken German and English language skills.
  • Strong communication and teamwork skills.
  • Flexibility to adapt to a wide range of tasks.