QA Specialist Quality Management System (QMS)

QA Specialist Quality Management System (QMS) (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.

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.

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.

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.