Responsible for ensuring PDx regional quality and regulatory compliance of PDx Latin America region, while driving process effectiveness and efficiency. The QA Manager represents GE Healthcare PDx to external agencies and champions the evolution of the quality culture for the region.Main responsibilities:- Drive and execute region quality priorities, objectives, metrics, reporting and operating mechanisms. - Drive Quality Culture, influencing Quality Metrics and region / sites… Show more Responsible for ensuring PDx regional quality and regulatory compliance of PDx Latin America region, while driving process effectiveness and efficiency. The QA Manager represents GE Healthcare PDx to external agencies and champions the evolution of the quality culture for the region.Main responsibilities:- Drive and execute region quality priorities, objectives, metrics, reporting and operating mechanisms. - Drive Quality Culture, influencing Quality Metrics and region / sites compliance to Quality policy, QMS procedures and tools, Quality Guidelines and Requirements. Contribute towards strategy and policy development;- Ensure quality and regulatory compliance while driving process effectiveness and efficiency;- Impact quality, efficiency and effectiveness of own team;- Represent GEHC PDx to external agencies;- Responsible for QMS in the region. Serve as best practice/quality resource;- Participate in selected global initiatives to share best practices and leverage quality synergies;- Use expertise and data analysis to support recommendations and drive changes, taking new perspective on existing solutions;- Impact approaches, projects and programs in the functional area or affected business organization and ways of working. Show less

Responsible for ensuring quality and regulatory compliance of a large and/or multi-modality facility (pharmaceutical, biopharmaceutical consumables, medical device) and for driving process effectiveness and efficiency:- Drive the definition of site QA objectives, metrics, reporting and operating mechanisms;- Influence QA Culture, QA Metrics and site compliance to QA policy, QMS procedures and tools, QA Guidelines and Requirements;- Participate in global initiatives to share best… Show more Responsible for ensuring quality and regulatory compliance of a large and/or multi-modality facility (pharmaceutical, biopharmaceutical consumables, medical device) and for driving process effectiveness and efficiency:- Drive the definition of site QA objectives, metrics, reporting and operating mechanisms;- Influence QA Culture, QA Metrics and site compliance to QA policy, QMS procedures and tools, QA Guidelines and Requirements;- Participate in global initiatives to share best practices and leverage quality synergies;- Maintain positive agency relationships-liaisons with regulatory agencies, customers, local distributors and other business partners; - Participate in external technical forums and benchmarking;- Ensure site audit readiness and host the QA System audits and inspections (internal, customer and regulatory); - Perform and oversee audits and quality agreements of third-party suppliers, distribution and other service providers;- Prepare, communicate, execute and report Quality Management System Reviews (QMS effectiveness);- Maintain and improve all aspects of Site Quality Planning;- Maintain QA Manual and oversee control of site quality documentation;- Oversee all QA related communications and training requirements;- Oversee the CAPA, Change Management, Non-conformities, Complaint Handling, Mock Recall and Route Qualification Programs;- Coordinate QC team to provide safe, compliant, timely and cost-effective support to the operation;- Coordination with Brazilian commercial strategy to ensure products are available for sales through batch release program;- Provide leadership and facilitate problem resolution, resource use, backup program and development of team members;- Owns site compliance assessment and remediation plans;- Support product launch programs and local strategy;- Act as Management Representative for QA at the site. Show less

Currently working in a pharmaceutical company with 2 main roles:- QA Specialist: supplier and business partner QA mgmt, internal and external audits, customer QA evaluation and mgmt, promotional materials and physician samples QA mgmt, batch release, QA documentation mgmt, gap analysis of regulation, metrics elaboration and analysis and other activities related to QA system.- Product Protection Specialist: management of counterfeiting – tampering – theft - diversion events involving… Show more Currently working in a pharmaceutical company with 2 main roles:- QA Specialist: supplier and business partner QA mgmt, internal and external audits, customer QA evaluation and mgmt, promotional materials and physician samples QA mgmt, batch release, QA documentation mgmt, gap analysis of regulation, metrics elaboration and analysis and other activities related to QA system.- Product Protection Specialist: management of counterfeiting – tampering – theft - diversion events involving pharmaceutical products, partners risk assessment, regulatory communications, internal and external trainings, coordination with internal and external stakeholders and with global teams. Leader of Product Protection Integrated Team in the Brazilian affiliate.Participation in pharmaceutical associations to improve processes, benchmarking and continuous updating.QA Representative in the Personal and Confidential Data Protection Team. Show less

Main activities:- Support in the investigation of complaints involving suspect samples;- Suspect Sample Authentication;- Regulatory Agency communications;- Implementation, review and update of security attributes applied on products;- Security Agreement implementation, periodical training and audit in suppliers;- Compliance with requirements involving controlled and special substances, in the manufacturing, affiliate and partners;- Internal and External… Show more Main activities:- Support in the investigation of complaints involving suspect samples;- Suspect Sample Authentication;- Regulatory Agency communications;- Implementation, review and update of security attributes applied on products;- Security Agreement implementation, periodical training and audit in suppliers;- Compliance with requirements involving controlled and special substances, in the manufacturing, affiliate and partners;- Internal and External trainings;- Product Protection Metrics;- Coordination with internal and external stakeholders and global teams. Main achievements:- Contact with global teams, partners, suppliers, external associations and academic environment.- English, audit techniques, negotiation and communication improvements. Show less

Main activities:- Focal point in the GMP audit program to manufacturing areas;- Knowledge in GMP, GDP and other pharmaceutical requirements;- Maintenance of Manufacturing Training Program;- Local implementation and expertise in the global training system;- Responsible for documentation management system in the affiliate;- Preparation and evaluation of training monthly metrics;- Training projects implementation;- Training materials’ technical… Show more Main activities:- Focal point in the GMP audit program to manufacturing areas;- Knowledge in GMP, GDP and other pharmaceutical requirements;- Maintenance of Manufacturing Training Program;- Local implementation and expertise in the global training system;- Responsible for documentation management system in the affiliate;- Preparation and evaluation of training monthly metrics;- Training projects implementation;- Training materials’ technical review;- Responsible for non-conformities investigation, CAPA proposal, change controls opening and audit response related to training system and documentation management system. Main achievements:- Extensive interface with manufacturing areas and company hierarchies;- Thorough vision of the training documentation engineering;- Broad vision of the manufacturing processes;- Experience in the audit response and presentations to the public. Show less

Main activities:- Maintenance of Manufacturing Training Program;- Local implementation and expertise in the global training system;- Preparation and evaluation of training monthly metrics;- Training materials’ creation and review;- Organization and accomplishment of GMP trainings – external and in company- Development and maintenance of internal controls;Main achievements:- Extensive interface with manufacturing areas and company hierarchies;- Thorough… Show more Main activities:- Maintenance of Manufacturing Training Program;- Local implementation and expertise in the global training system;- Preparation and evaluation of training monthly metrics;- Training materials’ creation and review;- Organization and accomplishment of GMP trainings – external and in company- Development and maintenance of internal controls;Main achievements:- Extensive interface with manufacturing areas and company hierarchies;- Thorough vision of the training documentation engineering;- Broad vision of the manufacturing processes and systems;- Experience in presentations. Show less

Main activities:- Register, monitoring and disclosure of QA metrics, trend analysis and periodical report release;- Trackwise system trainings to the manufacturing areas;- Organization and control of the Reference Area (retention samples), annual inspection and destruction;- Physical and electronic organization of the documents in the area;- Creation and maintenance of the procedures in the area.Main achievements:- Extensive interface with manufacturing areas and… Show more Main activities:- Register, monitoring and disclosure of QA metrics, trend analysis and periodical report release;- Trackwise system trainings to the manufacturing areas;- Organization and control of the Reference Area (retention samples), annual inspection and destruction;- Physical and electronic organization of the documents in the area;- Creation and maintenance of the procedures in the area.Main achievements:- Extensive interface with manufacturing areas and company hierarchies;- Operacional knowledge in the manufacturing CAPA system;- Knowledge in GMP and other pharmaceutical requirements;- Register improvement in the CAPA meetings;- Physical and electronic restructuring of the Reference Area (retention samples). Show less

Main activities:- Support to QA area in the technovigilance: notification to National Sanitary Surveillance System, documentation control, follow up with customers and process monitoring;- Support to QA area in the field actions and handling of non-conformities: notification to ANVISA, tracking and control of customers notification, documentation organization, process monitoring and action closure.- Support to QA area in the distributor’s communication;- Maintenance of database… Show more Main activities:- Support to QA area in the technovigilance: notification to National Sanitary Surveillance System, documentation control, follow up with customers and process monitoring;- Support to QA area in the field actions and handling of non-conformities: notification to ANVISA, tracking and control of customers notification, documentation organization, process monitoring and action closure.- Support to QA area in the distributor’s communication;- Maintenance of database to labels release (support to the logistic operation).Main achievements:- Knowledge in Technovigilance and Health Products’ GMP legislations;- Negotiation skills and communication with internal and external customers;- Improvements in the organization and creation of process control tools;- Development of English language to attend conference calls and to translate documentation.- Ability to deal with extra roles and responsabilities during the organisational restructuring period. Show less

Main activities:- Quality control of raw materials and diagnostic kits; - Execution of serology screening processes techniques; - Monitoring of QA indicators and participation of OPAS Performance Program in Serology.