QA Specialist

As QA Specialist you maintain a GMP compliant Quality Management System for the manufacturing and testing of raw materials and (biological) drug products based on applicable regulations and guidelines. You will have a diverse role in a high-paced environment, interacting with both our customers and internal staff.

Responsibilities:

• Investigating customer complaints and act as point of contact towards customers for Quality related matters;
• Review, assess and approve (complex) investigations related to deviations, non-conformances and out of specifications;
• Review and release of certificates of analysis, reports, materials, equipment and internal data;
• Review facility and environmental monitoring;
• Organize, host and support customer audits and regulatory inspections;
• Support and coordinate risk assessments;
• Review and approve batch records;
• Assist in maintenance and development of the QMS;
• Promote the awareness of quality, regulatory and customer requirements throughout the company;
• Lead and coordinate QA improvement projects;
• Act as deputy of the QA Manager.