[Quality/Consumer] Complaint Vigilance Associate (Contractor/ Japan)

The position holder: Processes product quality complaints (primarily DCl Products), reviews and approves complaint in accordance with Standard Operating Procedures using the Complaints Management System. This may include, but is not limited to, review complaint case to verify customer verbatim, lot number, subject coding, trend analysis, investigation, malfunction coding, and complaint closure as applicable. Coordinates with DCL Supplier (EM site’s) for Complaints requiring EM site’s Investigation and documents the investigation results along with the summary into PQMS. Collaborates with Call Centers, Medical Safety, Marketing, Internal affiliates, External sites, and other business partners to ensure the integrity, consistency, compliance, and alignment of the end-to-end complaint vigilance process. Assists with developing training presentations for complaint vigilance process and systems and creation and updates of controlled documents. Analyzes data, prepare trend reports, complaints metric and present to management and business partners as needed. Provides periodic training and support to triage and investigation team in execution of the complaint and processes to ensure compliance to the complaint management process. Supports management reviews and audit management. The position holder assists with various projects within the department, communicate effectively with all levels of management. Qualifications - External Qualification and Experience required: Master’s/ Bachelor’s degree in Pharmacy, Science discipline with a minimum of 2 years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical, medical devices or other related or highly regulated industry. Technical Competencies: -Demonstrates knowledge and expertise in quality system global regulatory requirements, including ICH Q10. -Demonstrates understanding of medical/ product quality complaints and associated GMP compliance requirements. Able to understand/discern safety, business (legal), and compliance risks related to complaints and in achieving performance objectives / indicators. -Ability to evaluate quality system elements and recommend improvements to meet regulatory requirements. -Demonstrates understanding of basic manufacturing processes and associated GMP compliance requirements -Strong knowledge of GMP Regulations, Health Authority guidelines, ICH and ISO guidelines including but not limited to:, ICH Q7, Q8 and Q9, and ISO 10002, 9001, 13485, and 14971. 資格 -Demonstrated knowledge and expertise in quality processes and regulatory requirements. -Experience working in regulated environment MHLW (Ministry of Health, Labor and Welfare). -Experience supporting manufacturing, packaging, and development operations. -Experience supporting many/all aspects of the complaint vigilance life cycle for pharmaceutical, device, and /or cosmetic products. -Experience with one or more IT technologies supporting complaint handling. PQMS or similar system preferred. -Experience in the creation, update, and management of complaint files from complaint identification through closure. -Expertise with root cause analysis techniques including but not limited to: Brainstorming, data analysis and collection tools, 5 Whys, Fishbone (Cause and Effect), FMEA -Experience with tools and techniques supporting qualitative risk analysis -Experience with systems and tools supporting analysis and reporting. Skill ability: -Decision-making and problem solving: Deals with issues using deductive reasoning, critical analysis skills and systematic approaches. -Innovation/creativity: resourcefulness, inventiveness, or creativity is required to devise methods, procedures, products, scientific applications etc. Deliver value-added business results through execution and controls. -Excellent communications (verbal, written and listening) and collaboration skills – demonstrated through work, projects, presentations, accurate information gathering, and productive discussions/results -Professional skills in the English language, both in spoken and written. *Johnson & Johnson Family of Companies in Japan strongly recommends prospective employees to complete the COVID-19 vaccination before or as soon as after joining our company to prevent the spread of infection among our employees and people around them as well as our customers and the community we serve, and to ensure our responsibilities are sustainably fulfilled as a healthcare company (except for those who cannot vaccinated with underlying medical conditions and other circumstances). * Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of a new entity within New Consumer Health and your employment would be governed by New Consumer Health’s employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by New Consumer Health at an appropriate time and subject to any necessary consultation processes. プライマリ場所 日本-東京都-千代田区- 組織 Johnson & Johnson K.K. (8235) ジョブ General Administration Requisition ID 2105995121W