Quality Specialist - Maternity Leave Lazio

Quality Specialist - Maternity Leave
Roma
Lazio, Lazio

Quality Specialist - Maternity Leave Quality Specialist - Maternity Leave Apply locations Italy - Rome time type Full time posted on Posted 2 Days Ago job requisition id 31109432 JOB DESCRIPTION: Primary Objective of Position Maintain Quality System compliance with Abbott/ ADC Commercial Quality System (QS) and local laws and regulations. Ensure that all relevant requirements are met prior to distributing product in Italy country. Major Accountabilities Maintain the local Quality System, specifically: Maintain specific processes in collaboration with the SME e. g. Field communications, supplier evaluation, competence management, Distributor management, Management Reviews, Warehouse Control, CAPA, Promotional Materials, Quality Hold, Document Control and Record Keeping according to established and/or newly developed procedures (e. g. OneAbbott) and supports further developments. Participates in Quality System improvements and implementation projects MIMS Subject Matter Expert & Procedure Owner. Review Abbott policies & procedures, and update Quality documentation accordingly. Supports/ prepares/ coordinates internal and external audits for Italy Affiliate. Supports commercial organization in the contracts and public tenders (QA requirements). Performs evaluation, re-evaluation and monitoring of suppliers/ distributors/ warehouses. Evaluate Third-Party Warehouses and Distributors with respective on-site audits (as appropriate). Support of medical event reporting and field actions in close cooperation with Product Quality Assurance (PQA), Customer Service, Regulatory Affairs and Vigilance/ Medical Event Group (MEG). Supports local complaint handling/ product replacement process. Prepares, updates to Personnel related documents such as organization chart, job description and training plans. Maintain and Ensures QS training programs in that all relevant employees are trained, and records maintained. Initiates, supports, and participates in Quality System improvements and implementation projects. Ensures that all activities are performed in compliance with quality system requirements. Education Scientific background (i. e. Biology, Chemistry, Pharma, M. D. ) preferred. Other education is acceptable if experience of 3 or more years in similar position. Background Preferably 2-3 years of experience in the Medical Device Industry or Pharma in the area Quality. Solid technical understanding/ scientific knowledge of products. Excellent organization skills. Knowledge of PC-based applications, such as Microsoft Office. High Proficiency in English language. Impact of position Implementation of quality processes and compliance assurance with Abbott's quality procedures and regulations. Maintain Affiliate QMS to ensure compliance with quality policies, procedures, and requirements regarding commercial/ business processes. Quality Representative for Affiliate. The base pay for this position is N/A. In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: ADC Diabetes Care LOCATION: Italy> Rome : Via Giorgio Ribotta 9 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable About Us Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges. We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. J-18808-Ljbffr