QA Specialist or Professional for Development Operations and Compliance
2 weeks ago
Seeking a meticulous QA Professional to spearhead Quality Oversight of outsourced development activities, ensuring compliance with regulatory requirements.
About Ascendis Pharma A/S: We're a biopharmaceutical company leveraging our TransCon technology to pioneer new therapies addressing critical medical needs.
We're currently hiring for a dedicated QA Specialist / Professional to join our highly skilled QA team in Copenhagen. As a key contributor, you'll play a pivotal role in driving the quality oversight of our outsourced development projects, working closely with global teams to achieve our goals.
Your main responsibilities will include:
- Ensuring quality oversight of complex analytical and manufacturing activities at Contract Organizations worldwide.
- Collaborating with our CMC department's development SMEs to drive development and guide them on quality-related topics.
- Supporting the quality work and quality oversight needed for our fast-paced development organization.
Requirements:
- A relevant academic degree, preferably a Masters' degree in Pharmaceutical sciences, Chemistry, Biotechnology, Engineering or equivalent, with over 2 years of experience in a GMP environment.
- Familiarity with outsourcing of analytical methods and analytical development.
- Knowledgeable about health authority regulations and their interpretation.
Key Competencies:
- Critical Thinking: Ability to analyze situations and data to make informed decisions.
- Solution-Oriented: Focuses on identifying and implementing effective solutions to problems proactively.
- Pragmatic Mind-Set: Approaches tasks and challenges with practical and realistic strategies.
- Communication Skills: Excellent ability to convey information and ideas effectively.
Estimated Salary: €60,000 - €80,000 per year, depending on qualifications and experience.
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