Pl Quality Analyst
2 semanas atrás
At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.**PL QUALITY ANALYST - FIXED TERM 12 MONTHS - JANSSEN SJC****Key Responsibilities**:- Be part of New Project as quality representative addressing the needs to guarantee compliance in both JJ Standards and Regulatory requirements.- Ability to read and interpret global documents and regulatory requirements and translate/reflect it at local operational SOPs and work instructions as appropriate.- Identify and explore best practices to improve quality processes in support of Janssen Supply Chain areas.- Support site audit preparation, readiness, and response (JJRC, HA inspections among others).- Build, support, assess and review quality records as required (not limited to). E.g: investigations, CAPAs, change controls, risk assessments and changes to documentation and processes.- Support and drive the effective implementation and maintenance of Janssen QMS requirements, ensuring awareness and continuous education within the Quality Control and Supply Chain operation.- Independently provide appropriate and compliant GxP insights and resolves problems using quality tools and root cause analysis.- Support and drive the quality tools / IT systems are used.- Consolidate, analyze and track the metrics as applicable.- Identify, analyze and address gaps, recommend initiatives for continuous improvement and compliance enforcement.- Support other activities/projects as required.**Qualifications****Qualifications****Education**:- University/bachelor’s degree in pharmacy, Engineering, or related areas.- Requires a minimum of 3 Years of work experience in a Quality Role within Pharmaceutical, Cosmetics, Food, Medical Device company (GMP controlled environment).**Experience and Skills****Required**:- Proactive profile.- Good organization skill with ability to meet deadlines.- Ability to handle multiple tasks simultaneously.- Analytical, prioritization, and good communication skills, with the ability to communicate with different levels of the organization.- Strong team player with the ability to work across a diverse team.**Preferred**:- Previous Pharmaceutical industry experience working with different processes that are part of the quality management system.- Previous experience collaborating with regulatory agencies, e.g., ANVISA, FDA, etc.**Other**:- Language: Intermediate English (speak, written and listening).- No travel is required for this position.**Primary Location**Brazil-São Paulo-São José dos Campos-Rod.Presidente Dutra, Km 154**Organization**Janssen Cilag Farmaceutica Ltda. (7585)**Job Function**Quality**Requisition ID**W
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