Senior QA Specialist/QA Specialist

Ascendis Pharma

Copenhagen, Denmark

Description

As a vital contributor at Ascendis Pharma, you'll play a pivotal role in ensuring the QA oversight of the analytical development carried out at our Contract Laboratories and Manufacturing Organizations, working in a dynamic environment alongside global teams to achieve our final goals to deliver best in class products to our Clinical programs remarkable outcomes.

Your main responsibilities will include

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.

Qualifications and Skills

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

Key Competencies

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.

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