Analista de Qualidade SR - Business Quality - São José dos Campos, BR Johnson & Johnson CANDIDATAR-SE AGORA » Data: 31/10/2014 Descrição The Senior Analyst is expected to possess detailed knowledge of Cosmetics, OTC and Medical Devices products to ensure appropriate complaint handling management in accordance with Standard Operating Procedures and Global Procedures. This individual will perform complaint metrics, trend analysis and provide consolidated data to management. Shall pursue strong ability on collaboration and influence Business Partners (Quality & Compliance Organization, Internal and External Business Partners, Call Intake Centers, Safety Organization, Brand Protection). The individual will develop and deliver appropriate training to complaint management system end users, as well as communicate the value of GXP practices and complaint data to the business and provide guidance and direction on complaint management policies, standards and processes. The individual will identify and implement complaint process efficiencies. This will include assessing the impact of proposed changes within and across functional areas that impacts the complaint handling process. The Senior Analyst works independently, challenges the status quo, identifies gaps and drives process improvements using Process Excellence tools. Serves as focal point for Complaint Vigilance inside the region to ensure process harmonization. Participates on global projects and/or leads special projects. Qualificações A minimum of a BA/BS degree in Chemistry, Pharmacy or Engineer is required. An advanced degree is preferred. Process Excellence certification or Project Management PMP is preferred. A minimum of 5+ years’ of related experience including Quality Assurance and/or Quality Control, including experience working in Pharmaceutical, Consumer and/or Medical Device or other highly regulated industry is required. Advanced English is mandatory, Spanish is a differential. Relevant knowledge on root cause investigations in a production environment is preferred. Experience supporting aspects of the complaint vigilance life cycle for pharmaceutical, device, consumer, and/or cosmetic products is required. Demonstrated knowledge of any of the following is required: manufacturing processes, regulatory requirements, including 21CFR, RDC 17/2010, RDC 16/2013 e RDC 48/2013. Strong communication, organizational and project management skills are required. Local principal: America Latina-Brasil-São Paulo-São José dos Campos Organização: J&J Brazil (7680) Área: Quality Assurance
Posted on: Sat, 08 Nov 2014 13:00:23 +0000
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