Project Manager

Vor 5 Tagen

Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

About Daiichi Sankyo Europe

Daiichi Sankyo Europe is a leading pharmaceutical company with a rich history of innovation and commitment to improving the lives of patients worldwide. With over 120 years of experience and a global presence in over 20 countries, we are dedicated to discovering, developing, and delivering new treatment standards that enhance the quality of life for patients.

Our Mission

We are driven by a passion to make a difference in the lives of patients and to be a leader in the pharmaceutical industry. Our mission is to provide innovative solutions that address the needs of patients and to be a trusted partner for healthcare professionals.

About the Role

We are seeking a highly skilled and experienced Project Manager to join our Quality Management team at our site in Pfaffenhofen/Ilm, Germany. As a Project Manager, you will be responsible for leading projects related to Fill & Finish and ADC Secondary Packaging, ensuring that all quality management aspects are met and that projects are delivered on time and within budget.

Key Responsibilities

  • Support the QA Project Team in developing and implementing quality management processes, including those related to CCS and QA Oversight
  • Take ownership of QA-related projects, including the setup and relocation of ADC Secondary Packaging lines in the Fill & Finish area
  • Collaborate closely with the project team, external service providers, and internal departments on quality management aspects
  • Support the QA Project Team in planning and designing clean rooms and production facilities, taking into account GMP requirements
  • Provide QA support in process validation and qualification activities, as well as document reviews (SOPs, risk analyses, etc.)
  • Support project-related QA questions that go beyond the scope of the F&F and ADC Secondary Packaging/Fill & Finish projects
  • Support the supervisor in QA-related tasks as needed

Post-Implementation Responsibilities

  • Take on QA management responsibilities (e.g., parts of QA Oversight) within the future production areas
  • Take on QA-specific tasks, such as:
    • Investigating and evaluating deviations and corresponding CAPAs
    • Supporting qualification/validation of equipment and processes
    • Conducting employee training
    • Performing charge documentation-related activities (provision, review, filing, archiving, and management)
    • Providing charge documentation at audits and inspections
    • Controlling output and managing forms
    • Supporting the supervisor in QA-related tasks as needed

Requirements

  • University degree, pharmacist, or equivalent qualification
  • At least 2 years of experience in quality management in a GMP-regulated environment
  • Desirable: additional experience in the area of secondary packaging in a GMP-regulated environment
  • Excellent knowledge of national and international regulations
  • Inspection experience, including US-FDA experience, desirable
  • Good MS-Office and SAP knowledge
  • Good German and English language skills in writing and speaking
  • Good team and communication skills
  • Exact working style and flexibility, as well as assertiveness
  • Willingness to engage with enthusiasm in building new areas for Daiichi Sankyo

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