QA Senior Associate – Manufacturing & Packaging Breda • SIRE Life Sciences

The Company
Our client is one of the biggest biopharma companies in the world. Focused on discovering, developing, and delivering innovative therapies for serious illnesses. With a strong foundation in biotechnology and a commitment to cutting-edge science, the organization emphasizes patient-centric solutions in areas such as oncology, nephrology, and inflammation. It operates with a clear mission to serve patients and improve lives through the power of biology, supported by a culture of integrity, collaboration, and continuous improvement.

The Role
The QA Senior Associate plays a key role in ensuring quality compliance and oversight in a pharmaceutical manufacturing environment, specifically at ABR (likely a packaging and labeling site). This position supports the end-to-end quality assurance process during the assembly, packaging, and labeling of pharmaceutical products.

Responsibilities 

• Provide on-the-floor QA support during packaging and labeling operations

• Review batch records before, during, and after production; ensure compliance for QP disposition

• Act as first QA contact for production-related quality issues

• Conduct finished product checks and GMP compliance inspections

• Approve and investigate deviations; initiate and manage QA deviations as needed

• Draft, review, and update SOPs and Work Instructions

• Support and deliver GMP training to QA and production teams

• Collaborate with Production, Warehouse, Engineering, and QA Management

• Contribute to quality projects, investigations, and process improvements

• Maintain weekly/monthly QA metrics and departmental performance boards

• Ensure compliance with GMP, GDP, and relevant regulatory standards

• MBO or BSc degree in Pharmaceutical or Life Sciences, or equivalent combination of education and experience

• Minimum 3 years of QA or manufacturing experience in the pharmaceutical or medical device industry, including batch record review and deviation handling

• Strong knowledge of GMP, GDP, and/or GCP, with the ability to interpret and apply these in daily operations

• Excellent communication, multitasking, and problem-solving skills; able to work under pressure in a production environment

• Full commitment to rotating 3-shift schedule (early, late, night); fluent in English

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