Über die Tätigkeit
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, monitorig, 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 standards, GMP, GDP, etc.) with the aim of achieving a 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 employees knows the applicable procedure and work accordingly.
• Maintain good contact with authorities with the aim of anticipating on 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.
Ihr Profil
• 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 Microsof office
• Experience with ERP systems and ability to learn fast
Unser Angebot
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.