Senior QA Specialist / QA Specialist
Ascendis Pharma
- København
- Permanent
- Fuldtid
- Responsible for driving the Analytical Quality Oversight for one specific project but also collaborating and contributing to the ongoing work at different other projects in our development pipeline
- Responsible for Quality Oversight of our outsourced analytical procedures at Contract organizations located all over the globe, including the complexity that such outsourcing activities add to an already complex analytical scope.
- Sparring with the team of highly skilled Analytical SMEs in the CMC department that drives the analytical development, both in-house but also at our Contract Organizations and guiding them in quality related topics.
- General support the quality work and quality oversight needed for a fast-paced development organization.
- You should hold a relevant academic degree, preferably a Masters degree in Pharmaceutical sciences, Chemistry, Biotechnology, engineering or equivalent with more than 5 years of experience in analytical work 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
- You're a team player, analytical, and approach challenges with a positive and constructive mindset.
- You thrive in an environment where innovation and adaptability are valued and required.
- To excel in this role, we expect you to be proactive, dare to take prompt decisions, and understanding when to involve and escalate if deemed necessary.