1. QA
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Quality Assurance (QA) consultant ATMP
Are you eager and enthusiastic to improve quality within the cell and gene therapy sector?
We are looking for a new colleague with thorough knowledge on QA processes, with experience (> 5 years) in a GMP environment ( pharmaceutical industry ). Experience in a commercial GMP manufacturing setting and ATMP’s are an advantage. Personal qualities that fit within our team: a strong and positive attitude, open to learn, straightforward (in a respectful way), innovative and love to search for new and better solutions.
Quality by Design (QbD) works in the international life science consultancy and partners with companies operating in ATMP, biotech, medical devices, IVD, digital health and pharma. We offer extensive knowledge and solutions in the direction of quality management, validation, project management and regulatory affairs. QbD is a rapidly growing company with an international presence, currently with 600+ employees in 11 locations worldwide.
What can you expect as a QA consultant ATMP?
2. You keep your knowledge within your expertise up to date with the latest guidelines, methodologies, and trends.
3. You provide advice and support on Quality Management Systems, corrective/preventive actions (CAPA), change control, processes, and complaints.
4. QA batch record review, support materials release and support batch release process.
5. Collaborate with internal and external stakeholders to improve quality.
6. You will work in an innovative environment in the field of cell and gene therapy.
7. Teamwork within a QA team.
Who are we looking for?
8. You have a scientific Master’s degree in (industrial) pharmacy, bioengineering, biomedical sciences, or similar.
9. You have a minimum of 5 years’ experience in QA in a GMP environment, preferably in a commercial GMP manufacturing setting.
10. Experience and interest in ATMP’s are an advantage.
11. A keen eye for detail and product quality is your main concern. You think and act in a structured way, are flexible and stress resistant.
12. You are available for 40 hours per week.
13. Location: Randstad, NL, Language: English
Curious to learn more on this opportunity and QbD? We look forward to hear from you and see if there is a match within our team!