Quality Assurance Specialist for Development GMP Activities

4 weeks ago


Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time
Job Title: QA Specialist for Development GMP Activities

Ascendis Pharma A/S is seeking a highly skilled QA Specialist to join our Development QA - Chemistry team in Copenhagen. As a key member of our team, you will play a vital role in ensuring the quality oversight of our outsourced development activities.

Key Responsibilities:
  1. Drive quality oversight for development projects and collaborate with global teams to achieve our goals.
  2. Responsible for quality oversight of outsourced complex analytical and manufacturing activities at Contract organizations.
  3. Sparring with development SMEs in the CMC department to guide them in quality-related topics.
  4. 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.
  • 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 and Office:

Approximately 20 days of travel per year. Office located at Tuborg Boulevard 12, 2900 Hellerup, Copenhagen, Denmark.



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