Posted in: May 4, 2020
Job has been expired
Job Description & Specification:
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.
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.
English : Very good
Pharmacy / Pharmaceutical ,
5 - 5 Years
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