Your new company
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. The company focusses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, they have grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Your new role
In this role, you will be responsible for ensuring the quality and compliance of SAP Master Data and pharmaceutical artwork through thorough QA review and approval. You will manage and improve QA systems, contribute to SOP development and reviews, and support investigations and quality-related projects. Working closely with cross-functional teams such as Regulatory Affairs, Global Artwork, and Master Data, you will play a key role in maintaining data integrity, ensuring regulatory compliance, and supporting continuous improvement within a GMP-regulated environment.
Responsibilities (include but are not limited to): :
- Review and approve of Master Data related activities (such as critical value verification and Bill of Materials).
- Perform approval of artwork for medicinal products.
- Participate in operational life cycle management
- Act as author for operational SOP’s and Work Instructions
- QA Review of operational SOP’s and Work Instructions
- Participate in QA related projects as needed
- Assist in various investigations as needed
- Ensure compliance
- Develop solutions to technical problems of moderate complexity
- Screens, categorises, evaluates, reconciles reports and resolves data integrity issues.
What you'll need to succeed
Masters or Bachelor’s degree in Life Sciences or related field, or the equivalent combination of education and/or experience.
Previous experience in GMP/pharma.
3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry
Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
Fluent in English.
Accurate mindset
What you'll get in return
In this position you will receive a monthly salary beginning from €4,2000- €4500 gross per month, and your travel expenses will be covered. Due to our relocation policy, we can only consider candidates who reside in the Netherlands or live within a commuting distance from Breda for this vacancy.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. Senior Associate QA
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
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