Daniela Rosa Galdino Email & Phone Number

• Responsible for final review, ensuring timely review and follow-up on and approval of executed batch production records (BPRs) and associated documents per applicable procedures and guidelines (cp 89 – Media, Upstream and Downstream).• Ensuring the BPR process complies with GMP and regulatory requirements.• Partner with production to improve the “Right First Time” quality of approved BPRs, Batch Record review and approval cycle time.• Implement continuous improvements – SMS 2.0 deployment.

Toronto, Ontario, Canada

• Backfill QualiPSO, providing services related to QualiPSO HSE data transference (CAPAS, accidents and safety events, risk assessment, etc.).• Document control.• Controlling training programs and KPIs.• Communication channels.• Improvements.• 5S.

Toronto, Ontario, Canada

• Lead investigation for Engineering Technical Service deviations.• Authors and ensure timely completion of comprehensive technical reports and documenting critical equipment/facility failure investigations, including assessing process/product impact and quality dispositions.• Manage and execute investigations in the nonconformance management process to determine the root cause of deviation events.• Establish and implement effective corrective and preventative actions with Subject Matters Experts (SMEs) and Quality Operations (OQ/OQSA) to eliminate event recurrence.• Create and manage associated Change Controls and CAPAs.• Technical writing. Document and generate comprehensive technical reports involving deviation investigations, including equipment or facility-related deviation events impacting GxP operations.• Manage associated documentation and timelines.• Continue state of compliance – ETS Daily Deviation, Deviation Review Board (DRB), +QDCI.• Support compliance directives, including internal and regulatory audits for the Technical Services Compliance Department.• Support manufacturing investigations, minor/major non-conformance investigations and development of templates as required.

Sumaré, São Paulo, Brazil

• Responsible for all the development of products and quality (quality control and quality system) for the four business units (PVC laminate, fabric stamping, fibers, nonwoven).• Writing procedures and ensuring their application.• Review and guide reports prepared by technical staff.• Prepare for regulatory inspections by drafting investigation briefing packages as applicable.• Supports the execution of stakeholders’ projects, ensuring full compliance and timely work implementation.

Itupeva - Sp

Main responsibilities:• Management and development of the Color Designers team, providing technical solutions to customers in color products and additives for polymers, seeking productivity and quality; • Support to quality control teams, production, and process engineering regarding product stability, the introduction of new products, training, process follow-up, and action plans; • Coordinated the raw material replacement program to ensure the improvement of product technology, production, and optimization of profit margins; • Quality Management System (ISO) Internal Auditor and tutor for the new auditors; • KPI control; • Responsible for investigating, addressing, and performing corrective actions to customer complaints;• Writing procedures and ensuring their application;• Ensuring that all key site personnel were appropriately trained and applying policies and procedures;• Writing and/or revising standard operating procedures for equipment and procedures throughout the company;• Regulatory status (ANVISA/MERCOSUR and FDA) to integrate the developments made in the different parts of the world.Main Results:• Saving USD41K – Spotlight Award in recognition of the work with a multidisciplinary group to find raw material options to enable converting cost-sensitive projects, especially in the polyolefin market. The options impacted not only those projects but also existing products.• Improve the KPI for first color design approval from 51% to 75%.• Kaizen Projects (Product cost reduction, Feedback about sample trials, Improvement of technical assistant performance, etc.).• Implementation of +QDCI program (visual indication management system).

Itupeva - Sp

Main responsibilities:• Product development according to customer requirements and business strategy together sales, supplies and pricing.

Americana - Sp

Main responsibilities:• Performance at the Colorants Laboratory testing compatibility between colorants and paints (water and solvent based);• Color development according to customer requests, both to solve product problems and to develop tinting systems, researching and proposing suitable adjustments in the formulation of paints sent to the laboratory;• Weekly contacts with the headquarters in the USA through teleconferences, phone calls, e-mails and reports;• ISO 9001 and 14001 maintenance (local RD).• Member and secretary of the CIPA (Internal Commission for the Prevention of Accidents) during 2005/2006. • Member of the Fire Brigade and of the group of volunteers of the company.Main projects:• English Day – a day per week to talk in English with everybody who speaks the language.

Campinas - Sp

• Researched and monitored activities in atmospheric pollution in a project involving UNICAMP/REPLAN (Paulinia refinery - PETROBRAS); • Development of systems for treatment and remediation of groundwater and soils contaminated with petroleum derivatives using advanced oxidative processes (AOPs), in a project involving UNICAMP/PETROBRAS-CENPES.

Chemistry By Universidade Estadual De Campinas – Unicamp, Chemistry

Undergraduate Degree: B.S. in Chemistry by Universidade Estadual de Campinas – UNICAMP. 2004. During the freshman year, participated.

Post-Graduate Degree: Mba With Focus On Strategic Business Management By Anhanguera Educacional., Business Management

Post-graduate degree: MBA with focus on Strategic Business Management by Anhanguera Educacional. Thesis: People: Management.