Quality Assurance Project Lead South Cluster

ppBefore you apply to a job, select your language preference from the options available at the top right of this page. /p pExplore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrow—people with a unique combination of skill + passion. If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level. /p h3Job Description /h3 pLocation: Somaglia (Lodi) (on site, with flexibility) /p pContract: permanent /p pWorking hours: standard /p pThe Healthcare Quality Assurance Project Lead South Cluster is responsible for coordinating and supporting quality assurance activities across healthcare projects, ensuring the effective implementation and maintenance of the Quality Management System in compliance with ISO 9001, ISO 13485, EU GMP, and EU GDP requirements. /p pThe role provides quality and compliance oversight for new buildings, client implementations, equipment, processes, audits, validations, risk assessments, change controls, and process improvement initiatives, while collaborating closely with internal stakeholders and external partners to ensure robust, compliant, and efficient project delivery. /p h3Responsibilities /h3 ul liCoordinate the implementation and the maintenance of the Quality Management System (QMS) in accordance with ISO: 9001 and ISO: 13485 standards, and in compliance with the EU GMP and EU GDP Guidelines. /li liApplies his/her knowledge, skills and tools in assessing and supporting Projects from the quality and compliance point of view. /li liCoordinate/execute various projects such as: ul liSetting up the QMS in a new Building, /li liAssessment of new Client opportunities, /li liImplementation of new Clients, /li liImplementation of new Equipment, /li liImplementation of new Processes, /li /ul /li liSupports External Audits within the scope of Project Management (e.g. new Client Audits, initial Regulatory Inspection). /li liConducts risk assessments on QMS processes to identify and mitigate any risks. /li liSupports with process validation on new processes and new Buildings. /li liSupport and complete Design Qualification in a new Building and/or with new Clients. /li liKeeps track of the projects, monitors the progress and identifies best practice and lessons learned. /li liCoordinates process improvements projects within the applicable departments /li liCreate and provide training related to Client implementation /li liCreate Change Controls for any Projects where applicable /li /ul h3KEY INTERACTIONS /h3 h3Internal /h3 ul liProject Management /li liOperations Management /li liQA Department / Document Control Department /li liSolutions / Implementations /li liSecurity /li liBaSe Team /li liProcurement Department /li liValidation Department /li liIT/ FUR Department /li /ul h3External /h3 ul liRegulatory Agencies /li liClients /li liSuppliers /li liThird Party Auditors /li /ul h3Qualifications /h3 h3Education level /h3 pBachelor's degree or International equivalent in Sciences- Required /p h3Pharmaceutical, Healthcare Or Food Industry Experience /h3 pPreferred /p h3Quality Assurance experience /h3 pPreferred /p h3Specialized Knowledge /h3 ul liProven experience in managing ISO: 9001 and/or ISO: 13485 standards /li liProven experience with GMP and/ or GDP guidelines is an advantage. /li liExperience with Supply Chain Industry is an advantage. /li liExperience with Root Cause Analysis tools (e.g. 5 why’s, FMEA) is a must. /li liExperience with Project Management is a must. /li /ul h3Skills /h3 ul liProficient in written and verbal English. /li liProficient in written and verbal Italian. /li liKnowledge of Spanish is a plus. /li liStrong verbal and written communication skills, to present recommendations and report back to different levels within the organization. /li liPreferably experience in technical writing of documentation. /li liProficiency in Microsoft Office (MS Word, Power Point, and Excel). /li liKnowledge of electronic Quality Management System is an advantage. /li liAbility to prioritize decisions which may have a significant risk for the company. /li liAbility to create networks and collaborate with various internal and external teams. /li liIdentify potential gaps in the processes and make recommendations for possible improvements. /li liCoordination of improvement projects where needed. /li liImplementation of new processes having a quality critical impact on the business. /li liRecommend training opportunities. /li liStrong organization, time management and planning skills. /li liFlexible in working hours. /li /ul h3Employee Type /h3 pPermanent /p pUPS is committed to providing a workplace free of discrimination, harassment, and retaliation. /p /p #J-18808-Ljbffr