O pracovní pozici
The Incoming Quality Specialist is responsible for ensuring the quality of raw materials that are received in from Supply Chain meet quality standards, and are safe for use in Fagron Products.
• Support all Incoming Quality Processes
• Collaborate with Training to create a training program for Incoming Quality
• Revise and create SOPs for incoming quality processes
• Develop process improvements for Incoming Quality processes
• Create Change Controls for raw materials
• Initiate investigations for Incoming Quality
• Trend data for Incoming Quality investigations
• Communicate and collaborate with Supply Chain, Production, Quality, and Quality Control on all Incoming Quality processes and the release status of raw materials tested for quality
• Assist CAPA teams, and other project teams, in the development of action plans and implementation schedules, and the verification of completed actions for Incoming Quality
• Maintain documentation for investigation outcomes.
• Disseminate written policies and procedures related to Incoming Quality activities.
Vystupte z davu
• BS/BA degree with 2 years of pharmaceutical industry experience in quality assurance/quality control or an equivalent combination of education and experience in a scientific or health-rated field
• Minimum 2 years directly related experience supporting compliance in a quality/compliance function or applicable compliance field.
• Knowledge of QMS and CAPA related tools or systems is preferred.
• Aseptic Experience is preferred
• ERP experience
• Working knowledge of applicable US FDA, USP and state board regulatory requirements and guidelines as applicable to the pharmaceutical industry.
• Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to detail.
• Strong interpersonal skills and the ability to assist personnel in a matrix organization, ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
• Flexible and able to adapt to company growth and evolving responsibilities.
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.