Over de functie
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, including certification processes for ISO 14385 & 15189. 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 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 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 communicates the QMS system within the organization.
Wat wij vragen
You possess the following qualifications, background and abilities:
Wat wij bieden
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.
Equal Opportunity Employer, including Disability/Vet
Over het bedrijf
Established in 1990, we have grown into a trusted global company becoming a leading player in personalized medical solutions. Thanks to our talented team of over 2,000 professionals located in 34 countries, we proudly satisfy the needs of over 200,000 customers around the world. From leading-edge compounding to natural products, from software to equipment, and pioneering genomics, we aim to deliver, on a global scale, ready-to-use and ready-to-administer innovative and high-quality personalized solutions that enhance medical compliance and significantly improve healthcare. Our people are driven by passion, a solid scientific core, and a dedication to innovate. We collaborate with our partners to continuously improve and discover new solutions, to bring quality to customers and positively impact people's lives.
Visit careers.fagron.com and discover your new career.
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