Job mission : Being responsible for managing, planning and organizing quality management system to comply with all regulations and continuously improve quality of our services. Ensuring compliance with all regulatory requirements for our products and services in the regions where we distribute them.
Key Responsibility Areas
* Manages corporate quality management programs. Develops and drives continuous improvement to quality system processes through the development, execution, monitoring, and reporting of Quality Plans.
* Undertake and manage regulatory inspections and audits. Prepare, manage and follow-up audits with the aim of achieving continuous improvement of the quality and processes.
* Supports the efficient and effective execution of the corrective action program, internal audit program, and other QMS subsystem elements, as well as the support of external audits and inspections.
* Translate the strategy into quality in actual projects in the frame of generally accepted quality standards, including GMP, GDP, etc., with the aim of achieving continuous improvement.
* Act as a qualified person with the aim of releasing products and analyses.
* Keep up to date with national and international legislation and guidelines. Continuously inform oneself about the latest trends in quality and keep one’s knowledge up to date in function of new developments in this field.
* Develop and implement processes with the aim of receiving approval for product and services.
* Identify compliance issues that require follow-up and conduct internal investigation of compliance issues with the aim of continuously looking for process improvements and ruling out non-compliance issues.
* Maintaining regulatory documentation database. Verify that all firm and regulatory policies and procedures have been documented and make sure every employee knows the applicable procedure and works accordingly.
* Maintain good contact with authorities with the aim of anticipating changes or new developments and trends within the sector.
* Plans and monitors training of people in the QMS and communicate the QMS system within the organization.
Minimum Requirements
* University degree in Pharmacy / Chemistry
* Minimum 2 years of relevant experience in Quality department
* Efficient and structured way of working
* Excellent skills to manage stakeholders and engage with people
* You are fluent in English
* Good working knowledge of Microsoft Office
* Experience with ERP systems and ability to learn fast
We offer a unique working environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where you need to be able to work independently. Fagron is a young, professional, and ambitious company with plenty of growth opportunities and we will offer you competitive compensation.
Fagron is the world's leading pharmaceutical compounding company and offers prescribers the broadest possible range of therapeutic options. We are committed to improving the lives of millions of people across the world by developing unique concepts and innovative solutions to meet the growing global demand for customized medication. We focus on personalized medicine so we can help everyone with medicine based on their needs.
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