GMP Quality Assurance Specialist Maternity Cover, Breda, Noord-Brabant

The Company
The client is a prominent leader in the biotechnology sector specializing in human medicines. This company has been at the forefront of developing new products using advancements in recombinant DNA and molecular biology, launching the first blockbuster in the biotechnology industry.    

Role Description
As a GMP Quality Assurance Specialist you’ll play a key role in ensuring the quality and compliance of investigational medicinal products (IMPs) used in clinical trials. You’ll oversee the QA aspects of clinical product handling - from receipt and labeling to packaging and distribution - ensuring adherence to GMP, GDP, and GCP standards. This position involves close collaboration with internal teams and external stakeholders to maintain high-quality standards throughout the clinical supply chain. 

Responsibilities

• Reviewing batch documentation to support Qualified Person (QP) certification of IMPs.
• Approving clinical label artwork and ensuring regulatory compliance.
• Assessing and documenting temperature excursions during transport and at clinical sites.
• Investigating and resolving quality and compliance issues related to clinical manufacturing and logistics.
• Reviewing and approving minor deviations, ensuring procedural compliance.
• Drafting and maintaining SOPs and work instructions aligned with corporate and regulatory standards.
• Preparing and reporting monthly quality metrics.
• Collaborating cross-functionally to identify and resolving operational issues.
• Providing on-the-floor QA support during clinical packaging and labeling operations, including pack checks and batch record reviews.
• Conducting QA compliance checks during manufacturing activities. 

Requirements

• Bachelor’s degree in Life Sciences or a related field.
• Minimum of 3 years’ experience in QA or manufacturing within the pharmaceutical or medical device industry.
• Solid understanding of GMP, GDP, and GCP regulations.
• Experience with batch record review, investigations, and analytical testing.
• Strong attention to detail and a compliance-driven mindset.
• Effective communicator with the ability to work across teams.
• Analytical thinker with problem-solving skills. 

Other information
Apply to our vacancy for more information. Looking forward to getting in touch! 

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