QA Specialist Breda • SIRE Life Sciences

The Company  
Our client who is values-driven organization with a strong mission: to serve patients. Combining the resources of a global enterprise with the innovation and agility of a biotechnology leader, they offer an environment where professionals can thrive. Our client is dedicated in high-quality medicines through a robust supply chain, advanced manufacturing, and clinical research. 

Role Description  
As a Senior Associate QA for Clinical Supply Chain, you will play a key role in ensuring the quality and compliance of clinical trial products. You will oversee clinical supply chain processes, provide QA support in clinical production, and work closely with various stakeholders to uphold Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards 

Responsibilities  

- Support batch review for Qualified Person (QP) certification of Investigational Medicinal Products. 

- Conduct compliance reviews and approve clinical label artwork. 

- Assess and manage temperature excursions during transport and at clinical sites. 

- Assist in resolving compliance and quality issues in manufacturing and distribution. 

- Review and approve minor deviations, ensuring compliance. 

- Develop and update Standard Operating Procedures (SOPs) and Work Instructions. 

- Prepare quality metrics and collaborate on issue resolution. 

- Provide on-the-floor QA support for Clinical Packaging and Labelling Operations. 

Requirements  

- Master’s degree in Science, preferably Life Sciences or a related field. 

- Minimum of 3 years of Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry. 

- Strong knowledge of GMP, GDP, and/or Good Clinical Practice (GCP). 

- Fluent in English. 

Other Information  

If you are interested in joining a team that is shaping the future of medicine, apply now via the link or contact Sofia Alftan. 

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