Quality Assurance Specialist for Development GMP Activities

2 weeks ago


Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full time
Job Description:

Ascendis Pharma invites you to explore the role of our newest QA Specialist / QA Professional for Development GMP activities. As a passionate Quality Assurance professional, you will play a pivotal role in ensuring the QA oversight of outsourced development activities carried out at our Contract Laboratories and Manufacturing Organizations.

Main Responsibilities:

  • Responsible for driving the Quality Oversight for a development project, collaborating and contributing to ongoing work at different projects in our development pipeline.
  • Responsible for Quality Oversight of our outsourced complex analytical and manufacturing activities at Contract organizations located globally.
  • Sparring with the team of highly skilled development SMEs in the CMC department, guiding them in quality-related topics within the quality management system and development/regulatory guidelines.
  • Providing general support for the quality work and quality oversight needed for a fast-paced development organization.

Qualifications and Skills:

  • A relevant academic degree, preferably a Masters' degree in Pharmaceutical sciences, Chemistry, Biotechnology, Engineering, or equivalent with more than 2 years of experience in a GMP environment.
  • Accustomed to working with outsourcing of analytical methods and analytical development.
  • Knowledgeable with requirements set out by different health authorities and interpretation of these.


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