- Prepares, reviews, and validates documents related to the granting and renewal of GMP (Good Manufacturing Practice) certificates for Active Pharmaceutical Ingredients (APIs), Medicines, and Health Products for both national and international manufacturers.- Monitors and controls the expiration dates of GMP certificates to ensure timely submission of documentation for the granting and renewal of certificates.- Participates in multidisciplinary meetings to understand and execute new… Show more - Prepares, reviews, and validates documents related to the granting and renewal of GMP (Good Manufacturing Practice) certificates for Active Pharmaceutical Ingredients (APIs), Medicines, and Health Products for both national and international manufacturers.- Monitors and controls the expiration dates of GMP certificates to ensure timely submission of documentation for the granting and renewal of certificates.- Participates in multidisciplinary meetings to understand and execute new projects.- Assesses regulatory risk for GMP certification projects.- Collaborates with the Quality, New Business, Research and Development, and Regulatory Affairs departments to form alliances and ensure alignment and compliance with international and national regulatory demands.- Contacts national and international partners for document requests and validation, scheduling inspections with Anvisa, and other necessary information.- Responds to official letters and requirements from Anvisa.- Contacts Anvisa to send documents via email, schedule inspections, and obtain pertinent information regarding the granting and renewal of GMP certificates.- Reviews the Official Gazette (Diário Oficial da União - DOU) to track publications of GMP certificates relevant to the company.- Issues alerts to the involved departments whenever there are publications of GMP certificates in the Official Gazette (DOU). Show less

- Created, reviewed, approved, controlled, and trained quality assurance documents such as Standard Operating Procedures (SOPs) and Manuals.- Coordinated quality management documentation using SoftExpert Excellence Suite software, including organizing, reviewing, creating, and canceling documents.- Actively participated in the validation of the SoftExpert Excellence Suite computerized system, preparing operational and parameterization manuals, participating in system risk management… Show more - Created, reviewed, approved, controlled, and trained quality assurance documents such as Standard Operating Procedures (SOPs) and Manuals.- Coordinated quality management documentation using SoftExpert Excellence Suite software, including organizing, reviewing, creating, and canceling documents.- Actively participated in the validation of the SoftExpert Excellence Suite computerized system, preparing operational and parameterization manuals, participating in system risk management meetings, and in the stages of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Played a key role in the team responsible for system validation.- Served as the system administrator for the SoftExpert Excellence Suite software, responsible for parameterizing all processes according to company demands.- Coordinated the Supplier Qualification process.- Coordinated the handling and response to Customer Service requests (SAC), collaborating with the responsible analyst to resolve issues and attend to customers.- Coordinated the Pharmacovigilance and Technovigilance processes.- Managed the entire non-conformance process from initial root cause analysis to treatment and closure. Also coordinated the development of Corrective and Preventive Actions (CAPA).- Coordinated the change control process management and treatment.- Coordinated, assisted, and evaluated the risk management process, from developing the risk analysis matrix to finalizing the process.- Responsible for monitoring cold chain medications, approving and releasing thermolabile drugs for distribution. Addressed issues with Anvisa (Brazilian Regulatory Agency) and prepared responses to inquiries related to drug distribution.- Assisted in the creation of quality indicators.- Led the team of analysts. Show less

- Reviewed manufacturing dossiers to ensure product quality.- Monitored the packaging process of health products and medicines, following it step by step.- Created and trained quality management procedures, such as Standard Operating Procedures (SOPs) and Manuals.- Assisted in managing quality documentation manually and participated in the transition to using the Excellence Suite software.- Assisted in the management and administration of quality management documentation through… Show more - Reviewed manufacturing dossiers to ensure product quality.- Monitored the packaging process of health products and medicines, following it step by step.- Created and trained quality management procedures, such as Standard Operating Procedures (SOPs) and Manuals.- Assisted in managing quality documentation manually and participated in the transition to using the Excellence Suite software.- Assisted in the management and administration of quality management documentation through the SoftExpert Excellence Suite software.- Handled calls and prepared responses for the Customer Service (SAC).- Assisted in Pharmacovigilance and Technovigilance processes.- Managed and addressed non-conformities, assisting from the start of the process by identifying the root cause to its closure, planning, and managing all stages.- Managed and handled the Change Control process.- Participated in internal and external audits.- Monitored the cold chain and importation of thermolabile medicines.- Analyzed documentation, followed up, approved, and released thermolabile medicines for distribution. Resolved issues with Anvisa by preparing responses related to drug distribution.- Evaluated post-incident drug loads.- Participated in all stages of the validation process of the SoftExpert Excellence Suite computerized system.- Parameterized the SE Suite system processes according to company demands. Show less

- Assisted in the evaluation of the Manufacturing Dossier, performing initial checks to ensure the quality of medicines.- Assisted in the management of Quality Assurance documents, participating in the entire process of document management, control, and updates within a quality management manual process.- Assisted in monitoring the manufacturing (packaging) process of medicines to ensure compliance with quality standards.

- Project Description: Evaluation of Angiotensin-Converting Enzyme (ACE) Polymorphism in Women with Thrombotic Events Associated with the Use of Combined Oral Contraceptives.MAIN RESPONSIBILITIES:- Participant Recruitment: Identification and recruitment of women with a history of venous thromboembolism caused by combined oral contraceptives.- Sample Collection: Assisting in the blood collection from participants, ensuring clear and detailed explanation of the Informed… Show more - Project Description: Evaluation of Angiotensin-Converting Enzyme (ACE) Polymorphism in Women with Thrombotic Events Associated with the Use of Combined Oral Contraceptives.MAIN RESPONSIBILITIES:- Participant Recruitment: Identification and recruitment of women with a history of venous thromboembolism caused by combined oral contraceptives.- Sample Collection: Assisting in the blood collection from participants, ensuring clear and detailed explanation of the Informed Consent Form (ICF), followed by obtaining the necessary signatures.- DNA Extraction: Performing DNA extraction procedures from the collected blood samples, ensuring the integrity and purity of the genetic material.- Genetic Analysis: Conducting RT-PCR to detect specific polymorphisms in the Angiotensin-Converting Enzyme (ACE) in the participants' DNA samples.- Data Processing: Statistical analysis of the obtained data using SPSS software, interpreting the results, and contributing to the conclusion of the study.- Literature Review: Searching for and reviewing relevant scientific articles to support the study, staying updated with the latest discoveries in the field. Show less

- Conducted analysis of lead and nicotine levels in urine samples from users and non-users of marijuana and cigarettes.

- Conducted analysis of heavy metals in blood, fish, hair, and urine samples, employing appropriate laboratory techniques and instruments to identify and quantify the presence of heavy metal contaminants.Co-author of the articles: Cadmium and lead in seafood from the Aratu Bay, Brazil and the human health risk assessment. Environmental Monitoring and Assessment, v. 188, p. 188-259, 2016.Risk Analysis For The Annual Seafood Consumption Of A Seaside Community. ISEE - Conference… Show more - Conducted analysis of heavy metals in blood, fish, hair, and urine samples, employing appropriate laboratory techniques and instruments to identify and quantify the presence of heavy metal contaminants.Co-author of the articles: Cadmium and lead in seafood from the Aratu Bay, Brazil and the human health risk assessment. Environmental Monitoring and Assessment, v. 188, p. 188-259, 2016.Risk Analysis For The Annual Seafood Consumption Of A Seaside Community. ISEE - Conference Abstracts, v. 2015, p. 7515 , 2015. Show less