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Manufacturing Quality Assurance Manager

vor 1 Monat


Oberursel, Hessen, Deutschland FRESENIUS_KABI Vollzeit

As a key member of the Center of Excellence for Manufacturing Quality Assurance at Fresenius Kabi, you will play a pivotal role in establishing and implementing global quality standards for pharmaceutical manufacturing. Your expertise will be instrumental in driving continuous quality improvements within the organization.

Your Responsibilities

  • Develop and implement global quality standards for the manufacturing of pharmaceutical products
  • Lead and contribute to projects aimed at implementing global quality standards, ensuring seamless execution and effective communication
  • Identify opportunities for improvement at both global and local levels, analyzing data to inform strategic decisions
  • Provide support to global manufacturing sites in root cause analysis of deviations and implementation of corrective actions, ensuring compliance with GMP regulations
  • Create and manage global quality management documents, maintaining accuracy and consistency
  • Support cross-functional projects within the Quality Management Pharmaceuticals team, fostering collaboration and knowledge sharing
  • Assist in the organizational duties of the Competence Center Manufacturing Assurance, ensuring smooth operations and effective communication
  • Build and maintain product and process knowledge, staying up-to-date with industry developments and regulatory requirements
  • Maintain and update the Confluence Spaces for the Competence Center Manufacturing Quality Assurance, ensuring timely and accurate information

    Your Profile

    • Bachelor's or higher degree in Pharmacy, Engineering, or other relevant natural sciences
    • 3–5 years of experience in pharmaceutical sterile manufacturing, with a strong understanding of GMP regulations and standards
    • Project management experience is highly desirable, with a proven track record of successful project delivery
    • Excellent communication skills in English, with a further language a plus
    • Willingness to travel, including extended periods, with a flexible and adaptable approach
    • Self-motivated, independent, team-oriented, and culturally aware, with a strong ability to abstract thinking, prioritize, and lead projects