Quality Specialist - Maternity Leave Lazio

Quality Specialist - Maternity Leave
Roma
Lazio, Lazio

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 as 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 ensure 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 a similar position.

Background Preferably 2-3 years of experience in the Medical Device Industry or Pharma in the area of Quality. Solid technical understanding/ scientific knowledge of products. Excellent organization skills. Knowledge of PC-based applications, such as Microsoft Office. High proficiency in the 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.

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