GMP QA Specialist – Rotational Shifts Breda • SIRE Life Sciences

The Company: 
Our Client is a values-based organization with a powerful sense of shared purpose toward their mission: to serve patients. Within Global Commercial Operations, they provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and verve that marked our early days as a biotechnology pioneer. Our client encourage team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities. 
 
Role Description: 

We are seeking an outgoing, communicative, and detail-oriented QA Associate to join our clients Quality team at the ABR facility. This is a hands-on role supporting daily manufacturing operations in a fast-paced, GMP-regulated pharmaceutical environment. You will be the first point of contact for quality issues on the production floor and play a key part in batch release, compliance, and continuous improvement efforts.

Note: This position follows a 3-shift rotation and requires 100% commitment to the following schedule:

• Early Shift: 06:30 – 15:00

• Late Shift: 14:30 – 23:00

• Night Shift: 22:30 – 07:00
   

• Provide daily quality oversight and support to production, packaging, and labeling operations.

• Review and approve batch production record data entries before and after operations.

• Perform on-floor GMP compliance checks and finished product visual inspections.

• Act as a QA point of contact during production, assisting with SOP adherence and real-time issue resolution.

• Review and approve deviations; initiate and lead QA deviations when needed.

• Support documentation by writing and reviewing SOPs and Work Instructions.

• Assist with investigations, root cause analysis, and implementation of CAPAs.

• Participate in GMP training delivery and continuous improvement initiatives.

• Maintain and report on QA metrics, dashboards, and performance boards.
   

• Education: MBO or BSc in Pharmaceutical Sciences, Life Sciences, or a related discipline.

• Experience: Minimum 3 years in Quality Assurance or manufacturing in a GMP-regulated pharmaceutical or medical device environment.

• Strong knowledge of GMP/GDP/GCP and familiarity with batch record review and floor-level compliance support.

• Ability to multi-task and perform under pressure in a fast-moving production setting.

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