QA Specialist Quality Management System (QMS) Full-time (NL)

The QA Specialist QMS effectively performs activities to ensure compliance with applicable current Good. Manufacturing Practice (cGMP) regulations, corporate policies, and site standard operating procedures.

Key job responsibilities:

• Management of the Electronic Document Management System, i.e. MasterControl.

• Further develop and improve the Electronic Document Management System.

• Sysadmin for the Electronic Document Management System (also for other Symeres sites).

• Review and approve risk assessments.

• Execute trending reports.

• Supplier/contractor qualification.

• Execute internal audits.

• Follow-up, review and approve change controls, deviations, corrective and preventive actions (CAPAs) and effectiveness checks.

• Support writing/revising standard operating procedures and work instructions.

Qualifications

• At least HBO level or equivalent.

• At least 2 years’ working experience in a QA function.

• High level of initiative, flexibility, and problem solving.

• Good written and oral communication skills in English (Dutch fluency is a plus).

• Proficiency with Microsoft Office (Word, Excel, PowerPoint).

• Knowledge of an Electronic Document Management System is preferred.

• Working knowledge of cGMP is preferred.