QA Specialist- GMP
ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 160 enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the patients we serve.
Our Quality Assurance department is currently looking for a QA specialist - GMP (full-time), with experience both in the development and in the commercialization process of a product, to join our team.
Description of the role
As a QA Specialist-GMP (Good Manufacturing Practices) you will be responsible for the GMP related activities at ProQR and external CMOs (Contract Manufacturing Organizations) within the product development phase, including but not limited to:
- Review and approval of GMP related documents that are to be created during product development, e.g. manufacturing records, process descriptions and validation documentation;
- Review of batch release packages
- Review of analytical data, methods and validations
- Experience with validation master planning
- Follow up on deviations, CAPAs and changes
- Development/maintenance of GMP related procedures
- Execution of internal audits and external vendor audits
- Participating in project teams providing guidance regarding compliant development of a product
- Perform QA review on regulatory documentation
You will be working closely with our QP and the CMC-team (Chemistry, Manufacturing and Control) and you will be reporting to the VP Quality Assurance.
We expect our QA specialist - GMP to have:
- At least HBO+ education level or Bachelor degree preferably in the area of life sciences or Applied Science (BACs)
- Preferably at least 5 years of QA experience in a product development environment (pharma/biotech), covering all GMP aspects of QA
- Experience in the commercialization process of a product is a pre
- Excellent knowledge of spoken and written English
Skills and competencies that are required for making the difference:
- Decisive and proactive
- Accurate and quality aware
- Autonomous and also a team player
- A nice person :-)
We offer an exciting and innovative working environment in a very committed organization, with the following benefits:
- A competitive salary
- 8% holiday allowance
- 30 vacation days
- An annual performance bonus
- Stock options
- A premium-free pension plan
- A commuting allowance
- A subsidized staff restaurant
- Flexible working arrangements
- Unlimited (un)healthy snacks and drinks
- Employee events (boot camp, chair massage and other social events)
Do you think you can contribute in achieving our mission? If so, we’re looking forward to receiving your application by filling out our application form.
Please apply as soon as possible if you are interested in this position.
You can contact Laura Faber via email@example.com if you have any questions.
Please note that a screening is part of our selection procedure.