CQA Specialist

ppVantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. /ppWe believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. /ph3bYour Role at Vantive /b /h3pbThis is where your motivation addresses challenges /b /ppYou are accurate. You have an eagle eye, a sharp critical thinking and the willingness to learn, develop and improve. You embrace a challenge and truly apply the collaborative powers of the team to produce excellent results. You are motivated by work that is never the same from one day to the next. You can absorb and act on complex procedures and data and train the team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality. /ph3bYour Team at Vantive /b /h3pAs a CQA Specialist, you will report directly to the CQA/RA Manager Benelux. The Quality function values both working together as a team and independently. We draw energy from working in collaboration with internal and external stakeholders. As the company evolves, so does the way our team approaches work as it strives to create new development opportunities and new ways of working. /ph3bWhat you will be doing /b /h3ulliResponsible for maintenance of related regulatory licenses (WDA MIA). /liliResponsible for ensuring outsourced storage and distribution activities are in line with European and local legal requirements, and Corporate Quality Systems implementation in the Benelux local entities to ensure establishment and maintenance of required licenses (e.g. WDA, MIA, ISO 9001 and ISO 13485 certifications). /liliAct as the Post Market Surveillance and local contact person for medical devices. /liliResponsible for Quality Support to local business initiatives in collaboration with Quality Operations. /liliEnsuring that appropriate contacts with country Regulatory Affairs, Pharmacovigilance, third-party logistics (3PL) for Warehouse Distribution (WD), transporters and Businesses are maintained. /liliResponsible Person Back-up. /li /ulh3bWhat you will bring /b /h3ulliMaster Degree in Pharmaceutical Sciences, Medicine, Chemistry, Biology, Biomedical Sciences or Bio Engineering. Eligible as Responsible Person. /liliPreferable prior work experience in quality or equivalent experience within a pharmaceutical/medical device company, CRO or similar organization. /liliFluency in Dutch or French, and working proficiency in the other national language and English (written and spoken). /liliOffice basic knowledge required. /liliKnowledge of GDP and GMP standards and applicable quality systems in area of responsibility. /liliProduct and process validation methodology. /liliKnowledge of Medical Industry Processes. /liliIT functional knowledge (ERP systems, data management systems). /liliGood interpersonal and communication

skills:
ability to collaborate closely with different functions involved and with multicultural teams. /liliOrganizational and project management skills. /liliSelf-motivation and commitments. /li /ululliTrackwise, JDE, ERP system particular knowledge is a plus. /liliISO Certification knowledge is appreciated. /li /ulh3bReasonable Accommodation /b /h3pVantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, /ph3bRecruitment Fraud Notice /b /h3pVantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. /p /p