Lúcia Volta E Sousa

Experience

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  Sonae Distribuição

  Jan 2007 - May 2007

  Quality Technician- - Product Development

  - Participation in the project for Package and label changing of Modeloe Continente products, in accordance with label legislation.

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  Tabaqueira- Philip Morris International

  May 2007 - Feb 2008

  Quality Assurance Trainee

  - Understanding the tobacco quality assurance process.- Execution of Tobacco physicochemical analysis in the quality control laboratory.- SAP product parameterization.

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  FARMA APS

  Mar 2008 - Feb 2009

  Quality Control Analyst

  - Methods Validation execution, in accordance with quality standards and guidelines (e.g., ICH Q2 (R1).- Drug product analysis (release and stability studies), using several analytical techniques: UV/Vis (assay), HPLC and UHPLC (Identification, related substances, uniformity of content and assay), GC (residual solvents), dissolution (dissolution test and profile), desegregation and hardness.- Assure compliance on Good Manufacturing Practices (GMP).

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  Laboratórios Vitória, SA

  Apr 2009 - Jun 2009

  Quality Control Analyst

  - Drug product analysis (release and stability studies): FT-IR (identification), UV/Vis (identification and assay), HPLC (identification, related substances, uniformity of content and assay), dissolution, desegregation and hardness.- Assure compliance on Good Manufacturing Practices (GMP).

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  Schering-Plough Farma / MSD

  Jul 2009 - Jun 2011

  Quality Control Technician

  Product Quality Review (Stability studies and finished product)- Review of drug product analytical results (release and stabilitystudies).- Stability process management in accordance with the qualitystandards and guidelines (e.g., ICH Q1A (R2)).- Product Quality Review (gathering only the information for stabilitystudies and finished product).- Participation in the innovation project for the implementation ofFT-NIR methodology for raw material and plastic packagingcomponents identification.- Assure compliance on Good Manufacturing Practices (GMP). Show less

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  Schering-Plough Farma/MSD

  Jun 2011 - Nov 2011

  Quality Assurance Technician

  - Elaboration of Product Quality Review.- Batch record review.- Participation in OOS investigations and propose/track the corrective and preventive actions (CAPAS).- Assure compliance on Good Manufacturing Practices (GMP).

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  OM Pharma

  Dec 2011 - Nov 2013

  Quality Control Technician

  - Stability studies and drug product analytical results review.- Drug product analysis (release, IPC and stability studies), using several analytical technologies: FT-IR (identification and assay), UV/Vis (identification and assay), HPLC (identification, related substances, uniformity of content and assay), potentiometric titration (assay), dissolution (dissolution test) and Karl Fisher (water content).- Develop and implement an innovation project focused on the application of NIR spectroscopy for raw materials identification.- Assure compliance on Good Manufacturing Practices (GMP). Show less

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  Instituto Superior Técnico /Hovione

  Dec 2013 - May 2018

  Industrial PhD Researcher

  Establishing Quality-by-Design (QbD) principles to development and lifecycle management of analytical methods in pharmaceutical quality control.-Optimized time and resources by implementing the Quality by Design (QbD) approach in the development and validation of analytical methods in the pharmaceutical industry, enhancing method robustness and reliability.-Used risk assessment tools like FMEAs and Heat Maps to mitigate variabilities and managed the project independently.-Developed and presented various scientific communications at conferences.-Enhanced skills in project management, effective communication, team leadership, and delivering innovative solutions in a regulated environment. Show less

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  Hovione

  May 2018 - Mar 2022

  Analytical Chemist

  -Developed and implemented analytical methods to support the development of active substances, intermediates, and final products at various stages of product lifecycle, aligned with established quality standards and agency guidelines (ICHs, EMA, GMPs, and others).-Managed ongoing scientific and innovative projects, coordinating team activities and resolving technical issues, promoting a collaborative and high-performance environment. -Engaged various stakeholders, including clients, members from different areas and the area director. -Internal and external communication of all the scientific achievements, through oral communications, peer reviewed articles, and posters.-Prepared technical documentation.-Enhanced skills in leadership, effective communication, data analysis, project management, and solving complex problems, in a high regulated environment. Show less

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  LEF - Laboratório Estudos Farmacêuticos

  Mar 2022 - now

  Analytical Development & Validation Manager at LEF - Laboratório Estudos Farmacêuticos (ANF)

  -Manage a diverse portfolio of pharmaceutical projects (analytical development an validation) across various stages of the product lifecycle (R&D to commercial), involving different complex projects, within pharma and medicinal cannabis.-Oversee planning, budget, resource plan, objective definition, change, and risk management while leading cross-functional teams, including quality assurance professionals, project managers and laboratory technicians, ensuring a collaborative environment between teams.-Ensure effective collaboration and alignment to achieve project goals with national and international clients, with strong focus on customer satisfaction.-Prepare commercial proposals, including solution definition and BC (costs estimation and pricing definition).-Lead a team of 9 people, motivating them to ensure high performance and goal achievement,-Report directly to the company administration, providing regular updates on project status, key performance indicators and strategic recommendations. Show less