Marina Sousa

• Identify and report quality concerns to management, documenting On- Hold batch, issue quality alerts, and participate in continuous improvement initiatives to maintain high product standards • Support QMS functions, including managing Change Controls, Deviations, CAPA

• Preparation and execution of validation plans, protocols and associated deviations • Participate in cross-functional and direct training of validation personnel by maintaining and improving validation SOPs, forms and training • Assembling of diagnostic kits and verification of BMRs • Support site Quality Management System (QMS) process as applicable (Change Controls, Documentation Management, CAPAs/NCRs, Audit Readiness, Supplier Quality Management).

Work simulation program including developing, generating, and executing validation documentation in following areas: Cleaning Validation, Equipment & Utility qualification, Process Validation, Biopharma, Change Control and Investigated Non-Conformance’s and identified CAPA’s. Reviewed project documentation to ensure compliance of completed documentation.

Maintained and ensured compliance with the quality system application (ISO 9001, GMP) Managed Physical-chemical, metrological and sensorial analysis by monitoring performance activities associated with the raw materials and the final product (manufacturing, inspection, packaging, document review) Reviewed Corrective and Preventive Actions (CAPA) Conducted audits Provided non-conforming material investigation and improvement of processes Supported new SKU trials and first production

Responsible for developing and implementing Validation Master Plan activities Provided reports of the quality standard procedures Conducted effective internal audits of the plant-based on HACCP and Quality Management tools Controlled the management of Critical Equipment for Food Safety Improved by 4% the Microbiological Performance Indicators (Micro Index) by performing audits, processing information and taking appropriate action.

Developed studies by analysing the activation of inorganic substrates through irradiation by vacuum ultraviolet light Improved the adhesion of PDMS-Urethane based on coatings Tested the application of coating through spin coating method Improved the understanding of characterization step, which consists of the superficial energy analysis, by the contact angle, of coating strength with the pull-off test and a cross-cut test

Undergraduate Exchange in Materials Engineering

Undergraduate Exchange in Process Engineering