Quality Assurance Specialist

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

**Job Description**

The Quality Assurance (QA) Specialist of the Quality Assurance Group coordinates employees training process in accordance with GMP requirements, prepares and updates quality assurance documents, checks documentation related to GMP processes, participates in the resolution of deviations, non-conformities and complaints.

**Key responsibilities:**

+ Prepares, updates and reviews QA documentation in compliance with ISO 13485 and GMP requirements
+ Participates in quality assurance activities (investigates unplanned deviations and complaints, major change process supervision)
+ Coordinates GMP risk management processes: Ensures the implementation of risk management activities by participating in or advising the risk management team on risk assessment. Monitors risk control activities.
+ Coordinate initial and following trainings...