- We are looking for a colleague with passion for quality assurance to join the GLP QA team within QA & Knowledge Management as a QA Scientist.
- The GLP QA team assures Non-Clinical Safety Research by auditing study plans, data and study reports to ensure that data and study documents for the worldwide registration of new NCEs are compliant with Good Laboratory Practice. Moreover, GLP QA team conducts screen audits and compliance audits of contract research organisations abroad.
- We cooperate proactively with the organisation to obtain the most efficient quality system.
- Besides the quality assurance work we also review regulatory documents such as non-clinical overviews and non-clinical summaries and support the organisation with technical assistance to the EDMS system and administrative assistance to project overviews.
Your job and key responsibilities
As a QA Scientist, you will be expected to:
- Audit study plan, study data and study reports from our analytical laboratories or from contract research organisations.
- Lead audits of contract research organisations often placed in Europe or US.
- Be a QA contact person for a specific analytical laboratory.
- Be a QA focus team member in company development project teams in which you support the team with information on regulatory requirements.
A challenging position in a dynamic department with dedicated colleagues.
Our preferred candidate has the following professional and personal qualifications:
- Life science education e.g. Master degree in Pharmacy, Chemical Engineering or possess equivalent qualifications besides a strong interest in quality.
- At least 3-5 years’ of experience with GLP, GCP or GMP
- Lead auditor experiences
- Experiences within analytical science will be an advantage
- You must speak and write English fluently.
- Strong engagement, credibility and empowerment.
- Decisive and embrace complex tasks via constructive dialogue and in cooperation with QA colleagues and collaborators in Non-clinical Safety Research.
- Our company is a global pharmaceutical company specialized in psychiatric and neurological disorders.
- For more than 70 years, we have been at the forefront of research within neuroscience.
- Our key areas of focus are depression, schizophrenia, Parkinson's disease and Alzheimer's disease.
- An estimated 700 million people worldwide are living with psychiatric and neurological disorders and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences.
- Every day, we strive for improved treatment and a better life for people living with psychiatric and neurological disorders – we call this Progress in Mind.
- Our approximately 5,300 employees in 55 countries are engaged in the entire value chain throughout research, development, production, marketing and sales.
- Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries.