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Job Description
- Continuous improvement of a Quality Management System according to ISO 9001:2015 and global operating procedures of the company
- Maintaining the certification status of the organization
- Coordination and control of the activities to improve the QMS
- Preparation of Quality Management Reviews
- Supporting definition and implementation of quality policy and quality objectives
- Definition and follow up of quality indicator (KPI)
- Implementing the requirements from Quality Management Handbook
- Create and update local procedure descriptions (SOP’s, GD’s, WI’s)
- Training and Implementation of global procedures
- Performing internal and external audits
- Event handling: detection of gaps and non-conformities, definition and implementation of preventive and corrective action and effectiveness check of the implemented CAPA’s
- Managing the Change Control Process
- Managing the Complaint Process
- Supporting the planning and execution of training, mentoring and knowledge management process
- Supporting other company departments with quality related question
- Supporting Supplier Management Process and Customer Satisfaction Assessment.
Job Requirements
- University degree in Pharma, Science, etc.
- 5 year experience in the QM/QA area of a health care company
- Good knowledge in requirements of ISO 9001:2015, GMP, GDP, and local laws and regulation for a health care company
- Process and System Auditor training preferable
- Good English knowledge
- Good organization skills
- Good knowledge in common application software Office 365, Trackwise (preferable), eDMS, etc.
