Quality Assurance Sr. Analyst
2 semanas atrás
**Job Function**:Quality**Job Sub Function**:Customer/Commercial Quality**Job Category**:Professional**All Job Posting Locations**:São José dos Campos, São Paulo, Brazil, São Paulo, BrazilOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.Visionaries like you work on teams that save lives by developing the medicines of tomorrow.Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.**We are searching for the best talent for Quality Assurance Sr.Analyst to be in Sao Jose dos Campos or Sao Paulo, Brazil****Purpose**:Janssen-Cilag is recruiting for a(n) Quality Assurance Sr.Analyst, located in São Paulo/ São José dos Campos (hybrid - minimum 2 days presential in SJC)Quality Assurance Sr.Analyst will be responsible to support Logistic Quality Operations, under Commercial Quality scope and manage/ execute related project actions.Act as elaborator, reviewer for main qualification/ validation documents, Temperature monitoring and excursion, manage training activities related to project's scope, review operational procedures, and manage activities/ evidence related to change control and quality records.**You will be responsible for**:- Manage general activities under CQ - Logistics Quality scope.- Conducting processes of Investigation of Non-Conformities, CAPAs, Change Control.- Manage change control activities and gather pool of required evidence.- Support in activities and attendance of Quality Audit (Corporate and External) and implementation of any action plan related to project's scope;- Manage, prepare, and deploy required training related to Diamond project activities.- Preparation and Review of Risk Analysis for related processes.- Support in processes involving Regulatory Compliance.- Support and report KPIs and metrics in scope.- Support in review operational procedures and any improvement opportunity.- Elaborate and Review documentation mainly related to qualification/ validation activities and other processes.- Contribution to the fulfillment of the company's Quality/Compliance and EHS requirements.- Ensures the updating and maintenance of regulatory documentation related to the site under its responsibility.- Supports activities related to the J&J product warehousing and distribution process.**Qualifications / Requirements**:**Education**:- Education, preferably in Pharmacy, but can be related areasExperience and Skills:**Required**:- Minimum 5 years of experience in Quality Assurance in the pharmaceutical or related industry.- Good knowledge of manufacturing and distribution processes- Advanced English (Reading, Writing and Speaking)- Experience with Risk Analysis- Office Package (Intermediate-Advanced Excel)- Knowledge of Anvisa Sanitary Legislation related to GxP and Product Registration processes- Self-manageable profile focused on results and deadlines- Analytical-detailed profile- Equipping and interpersonal skills, interpersonal communication skills, providing a harmonious and interpersonal environment- Ability to lead by influence- Ability to act and manage projects simultaneously**Preferred**:- Comet knowledge - Desirable- Knowledge of SAP - Desirable
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