Vanessa Nascimento, Pmp Email & Phone Number

Contribute to the harmonization of the Business Unit Quality Management System by: • Planning, configuring and executing MasterControl implementations in sister labs in NA and EMEA. • Configuring and implementing new MasterControl modules. • Writing and implementing Business Unit Policies and Standard Operating Procedures (SOP). • Improving processes by replacing paper-based processes with the electronic QMS.

Santa Fe Springs, California, United States

• Planned, configured and executed GMP Software implementation (MasterControl).• Executed System Administrator activities for MasterControl documents, training, and process module.• Orchestrated the transition of ~150 SOPs from paper-based system to MasterControl, which included: collect requirements from stakeholders, define MasterControl configuration, document importing and end user training.• Assisted sister labs within Business Unit with creating and disabling accounts, new… Show more • Planned, configured and executed GMP Software implementation (MasterControl).• Executed System Administrator activities for MasterControl documents, training, and process module.• Orchestrated the transition of ~150 SOPs from paper-based system to MasterControl, which included: collect requirements from stakeholders, define MasterControl configuration, document importing and end user training.• Assisted sister labs within Business Unit with creating and disabling accounts, new hire training and troubleshooting.• Coordinated upload, approval and launch of SOPs and documentation placed in the MasterControl.• Assisted Quality Assurance Manager in SOP revisions. • Provided project management support for upcoming MasterControl modules and software implementation in sister labs within Business Unit. Show less

Greater Los Angeles, California, United States

• Managed complaints on implantable cardiovascular devices and their accessories.• Determined FDA reportability. When applicable, submitted a Medical Device Report to theFDA.• Applied analytical skills to evaluate complex situations using multiple sources ofinformation.• Acquired an in-depth knowledge on implantable cardiovascular anatomy, pathologies,devices functionality and device issues.• Professionally communicated with field personnel: physicians, nurses… Show more • Managed complaints on implantable cardiovascular devices and their accessories.• Determined FDA reportability. When applicable, submitted a Medical Device Report to theFDA.• Applied analytical skills to evaluate complex situations using multiple sources ofinformation.• Acquired an in-depth knowledge on implantable cardiovascular anatomy, pathologies,devices functionality and device issues.• Professionally communicated with field personnel: physicians, nurses, engineers, andhealth care professionals.• Acquired working knowledge of quality system requirements such as ISO 13485 andFDA’s 231 CFR Part 820• Complied with FDA regulations, other regulatory requirements, company policies,operating procedures, processes, and task assignments. Show less

Anaheim, California, United States

[Xerxes / ZCL / Shawcor]• Performed Quality and Safety Root Cause Analysis, created and monitored corrective and preventive (CAPA).• Mapped processes, wrote and implemented Standard Operating Procedures (SOP).• Worked with sister plants to standardize the Quality Management System.• Managed the Initiating phase of a US$300,000 Safety project.• Participated in a project that saved $1 million dollars per year by reducing material usage. • Improved the Safety Audit score in… Show more [Xerxes / ZCL / Shawcor]• Performed Quality and Safety Root Cause Analysis, created and monitored corrective and preventive (CAPA).• Mapped processes, wrote and implemented Standard Operating Procedures (SOP).• Worked with sister plants to standardize the Quality Management System.• Managed the Initiating phase of a US$300,000 Safety project.• Participated in a project that saved $1 million dollars per year by reducing material usage. • Improved the Safety Audit score in 11% compared to the previous year. Show less

Salvador Area, Brazil

• Implemented the Quality Assurance department. • Developed and implemented a plan for the ISO 9001:2015 certification.• Created the Quality Manual, wrote and implemented Standard Operating Procedures.• Reduced the quality escapes in 40% the errors by improving the shipping processes.• Performed Internal Quality Audits and wrote audit reports with CAPA.

Salvador Area, Brazil

• Managed the dialysate production processes: raw material purchase, incoming inspection, production, quality control, internal distribution, and disinfection of the distribution lines.• Reduced 30% of monthly costs with raw materials by remodeling the structure of the stockroom, changing the flux of operations, and improving the raw material preparation processes.• Created Key Performance Indicators (KPIs) for critical processes. • Managed non-conformances: performed Root Cause… Show more • Managed the dialysate production processes: raw material purchase, incoming inspection, production, quality control, internal distribution, and disinfection of the distribution lines.• Reduced 30% of monthly costs with raw materials by remodeling the structure of the stockroom, changing the flux of operations, and improving the raw material preparation processes.• Created Key Performance Indicators (KPIs) for critical processes. • Managed non-conformances: performed Root Cause Analysis, contacted suppliers, assigned and tracked CAPA.• Implemented the Adverse Event Reporting System, developed the processes of notification and risk responses, created procedures and forms, and trained the team on events notification.• Assisted the Quality Assurance team on the Hospital Accreditation re-certification by reviewing SOPs and performing cross-functional internal audits.• Managed the project of implementation of the clinical research center: developed multi-departmental processes, created SOPs and work instructions, and trained the team. Show less

Salvador Area, Brazil

• Reduced inventory loss due to expiration date on 20% by reviewing the process that generated automatic orders and managing the layout of the shelves.• Engaged in the community by promoting campaigns to provide information about public health, and offering free blood pressure and blood glucose measurements.• Managed customer service daily, providing orientation about medicines and handling customer complaints.

Project Management Certificate, Project Management

Awarded with Distinction

Certificate, Change Management

Bachelor Of Pharmacy (Bs Pharm), Science

Specialist, Business Administration And Management, General

Extension, Quality Assurance - Healthcare