Senior QA Specialist in Outsourced GMP Projects

3 days ago


Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full time

We are seeking a Senior QA Specialist to join our QA team in Copenhagen and contribute to the success of our outsourced GMP projects.

This individual will be responsible for driving quality oversight for development projects and collaborating with global teams to ensure compliance with regulatory guidelines.

The successful candidate will have a relevant academic degree and more than 2 years of experience in a GMP environment, with expertise in outsourcing analytical methods and development.

You will work closely with 10 colleagues and report to Director Jon Wriedt Poulsen, based in Hellerup, Copenhagen, Denmark.

Your main responsibilities will include:

  • Quality oversight of outsourced complex analytical and manufacturing activities at Contract organizations located globally.
  • Sparring with development SMEs in the CMC department to drive quality related topics within the quality management system and development/regulatory guidelines.
  • General support of quality work and quality oversight needed for a fast-paced development organization.

Key Qualifications:

  • Masters degree in Pharmaceutical sciences, Chemistry, Biotechnology, Engineering or equivalent.
  • More than 2 years of experience in a GMP environment.
  • Expertise in outsourcing analytical methods and development.

Competencies:

  • Critical thinking and problem-solving skills.
  • Excellent communication and collaboration skills.
  • Ability to work independently and as part of a team.

Travel: Approximately 20 days per year. Office: Tuborg Boulevard 12, 2900 Hellerup, Copenhagen, Denmark.



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