Quality Assurance Specialist for Development GMP Activities
4 weeks ago
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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