Senior Quality Assurance Specialist

Senior Quality Assurance Officer

LOCATION: Geleen

About the Role:

We are seeking a Senior Quality Assurance Officer to join a leading biotech/pharma organization. You will oversee quality processes, review critical documentation, support batch release, and drive continuous improvement while ensuring GMP compliance.

Key Responsibilities:

• Act as a Quality Subject Matter Expert, collaborating with internal teams and external partners.
• Review and approve batch records, deviations, CAPAs, and Change Requests within deadlines.
• Ensure timely closure and archiving of all batch-related documents.
• Participate in project meetings, providing quality guidance and input.
• Review and approve controlled documents like SOPs, forms, protocols, and reports.
• Monitor and report quality performance metrics.
• Support QA on the Floor activities, including manufacturing and warehouse operations.
• Mentor and train junior QA team members.

Requirements:

• Bachelor's or master's degree in science, Biotechnology, or related field.
• 5-10 years of Quality Assurance experience in a GMP-regulated environment.
• Strong documentation, risk assessment, and problem-solving skills.
• Proficient in English
• Strong communicator with cross-functional teamwork experience.

If you are passionate about quality and ready to contribute to a high-performing team, we'd love to hear from you!