Quality Assurance Specialist for Development GMP Activities

4 weeks ago


Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full time
Quality Assurance Specialist for Development GMP Activities

Ascendis Pharma A/S is seeking a highly skilled Quality Assurance Specialist to join our Development QA team in Copenhagen. As a key member of our team, you will be responsible for ensuring the quality oversight of outsourced development activities carried out at our Contract Laboratories and Manufacturing Organizations.

Key Responsibilities:

  • Drive Quality Oversight for development projects and collaborate with global teams to achieve best-in-class products.
  • Responsible for Quality Oversight of outsourced complex analytical and manufacturing activities at Contract organizations.
  • Sparring with development SMEs in the CMC department on quality-related topics within the quality management system and development/regulatory guidelines.
  • General support for quality work and quality oversight needed for a fast-paced development organization.

Requirements:

  • Relevant academic 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.

Key Competencies:

  • Curiosity: Demonstrates a strong desire to learn and understand new concepts and ideas.
  • Solution-Oriented: Focuses on identifying and implementing effective solutions to problems proactively.
  • Pragmatic Mind-Set: Approaches tasks and challenges with practical and realistic strategies.
  • Guidance to Stakeholders: Provides clear and actionable guidance and sparring to both internal and external stakeholders.
  • Communication Skills: Excellent ability to convey information and ideas effectively.
  • Analytical Thinking: Strong capability to analyze situations and data to make informed decisions.
  • Collaboration: Works well with others to achieve common goals.
  • Adaptability: Easily adjusts to changing circumstances and environments.
  • Independence: Capable and thriving working autonomously and making decisions.

Travel: Approximately 20 days per year.

Office: Tuborg Boulevard 12, 2900 Hellerup, Copenhagen, Denmark.



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