Quality Assurance Specialist for Development GMP Activities
2 weeks ago
Ascendis Pharma invites you to explore the role of our newest QA Specialist / QA Professional for Development GMP activities. As a passionate Quality Assurance professional, you will play a pivotal role in ensuring the QA oversight of outsourced development activities carried out at our Contract Laboratories and Manufacturing Organizations.
Main Responsibilities:
- Responsible for driving the Quality Oversight for a development project, collaborating and contributing to ongoing work at different projects in our development pipeline.
- Responsible for Quality Oversight of our outsourced complex analytical and manufacturing activities at Contract organizations located globally.
- Sparring with the team of highly skilled development SMEs in the CMC department, guiding them in quality-related topics within the quality management system and development/regulatory guidelines.
- Providing general support for the quality work and quality oversight needed for a fast-paced development organization.
Qualifications and Skills:
- A relevant academic degree, preferably a Masters' 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.
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