andrea rojas moreira

Biotechnology specialist in Advanced Therapies

Científico

Santiago, Provincia de Santiago

Acerca de andrea rojas moreira:

Responsible, independent, proactive, with project leadership skills, and capable of managing multidisciplinary teams.
In the professional realm, my strengths lie in my ability to organize processes, continuously seek improvement, and resolve problems effectively. Furthermore, I adhere to high standards of best practices in documentation, manufacturing, laboratory, and clinical trials (GMP, GCP, ICH, and ISO 9001:2015 guidelines).
Regarding my soft skills, I am characterized by my positivity, cheerfulness, collaborative nature, and effective working relationships with coworkers, managers, and clients.

Experiencia

Deputy Manager of Operations

Medicel SA.

Santiago, Chile

Jul. 2021-Present

Essential Functions: Responsible for office management and supervision of all departments within the company (accounting, HR, finance, marketing, sales and production).

Regulatory requirements: Ensure that regulatory requirements are met in the production of biological products. Manage the processes to obtain different regulatory authorizations. Implement the necessary measures to meet the requirements that are deficient or lacking. Organize staff functions for the implementation of measures and their optimal execution.

Audits/Inspections: Internal auditing and inspections of laboratory production in compliance with ISO 9001:2015 standards, good laboratory practices (GLP), good documentation practices (GDP) and good manufacturing practices (GMP).

Document management: Supervise that the documentation is organized, available to be used and stored where it corresponds, following internal standard operational procedures (SOPs) and good documentation practice guidelines (GDP).

Data Management: Optimization of the Customer Relationship Management software for the traceability of the operations. Supervise the correct and complete traceability of the processes related to the sale and manufacturing of products, and the purchase of supplies or services. Ensure that the documents are completed in the appropriate manner and time.

Deadline tracking: Handling and oversight of key performance indicators (KPIs). Monitoring the execution of projects and the use of funds. Identification of needs for the execution of the projects.

Problem resolution: Understand and solve problems with a general approach, identifying all the areas that can be related. Problem-solving and resolution through root cause analysis (RCA) and corrective/preventive actions.

Safety reporting: Supervise that the presence of adverse events to the products delivered is monitored and that, if they exist, they are analyzed and reported as appropriate.

Supplies management: Supervise that there is sufficient stock of supplies, that their storage is adequate in the warehouses and that their storage temperature is as indicated by the manufacturer.

Funding management: Responsible of controlling budgets of projects and the different departments, and cost of the manufacturing process.

Team work: Coordination of work between departments. Motivate the team for continuous improvement following high quality standards. Responsible for serving clients and training them. Responsible for presenting technical information of the company to the regulatory authority (Chilean Public Health Institute, ISP). Responsible for supervising the management of supplies and service suppliers, defining requirements and controlling performance.

Achievements: Obtained health authorization for clinical laboratory from SEREMI. Obtained authorization for SARS-Cov-2 diagnostics from ISP. Obtained authorization of Sample Collection Room from SEREMI.

Qualified Person

Medicel SA.

Santiago, Chile

Oct. 2016 - Jul. 2021

Essential Functions: Led the production of the stem cell expansion laboratory.

Regulatory requirements: Ensure that laboratory team meets regulatory and good practice requirements. Ensure that the facilities in compliance with ISO 14644-1 (clean rooms).

Audits/Inspections: Responsible for coordinating the external audit process of the ISO 9001:2015 standard and for delivering the information requested during the execution of the audit.

Document management: Development of protocols following good documentation practices (GDP) and workflow process with a risk-based approach.

Data Management: Responsible for training production assistants to ensure the correct recording of information. Responsible for recording the progress of the manufacturing process in the corresponding documentation. Records review to evaluate data accuracy along the manufacturing process.

Deadline tracking: Responsible for ensuring that ordered products are delivered on time.

Problem resolution: Escalate quality issues as appropriate. Implement preventive and corrective actions.

Safety reporting: Responsible for recording and monitoring reported adverse events.

Supplies management: Responsible for procurement management of supplies (inventory, quotations, purchase orders, receipt and storage).

Funding management: Fund management for the maintenance of laboratory equipment.

Team work: Mentor/lead the work of the laboratory team. Coordinate supplies delivery with suppliers. Coordinate product delivery with clients.

Achievements: Implemented and certified ISO 9001:2015. Implemented laboratory and good manufacturing practices standards.

Clinical Trials Regulatory Affairs Coordinator

Center for Clinical Studies and Medical Research (CeCim) Bioclinica

Santiago, Chile

Dec. 2018 - May 2019

Essential Functions: Responsible for reporting and monitoring adverse events and protocol deviations to the ethics committee.

Regulatory requirements: Provided training to the clinical team on Good Clinical Practices (GCP) to comply with regulatory requirements.

Audits/Inspections: Support the clinical team with the information requested for monitoring visits.

Document management: Supported the clinical team with the creation, handling, distribution, recording, and storage of study documentation.

Problem resolution: Collaborate with the study teams, CRO, sponsor for the problem resolution.

Safety reporting: Elaborate and deliver reports to the ethics committee related to adverse events.

Supplies management: Assist in the control and recording of temperature of the investigational products as appropriate.

Team work: Collaborate with study team members for an adequate project execution.

Achievements: Reinforcement training in good clinical practices for the study team.

Production Manager

Vita Stem Cell Laboratory.

Santiago, Chile

Jun. 2017 - Nov. 2018

Essential Functions: Head of production and manufacturing of cellular therapies for veterinary purposes.

Document management: Development of protocols for manufacturing process.

Data Management: Responsible for recording the progress of the manufacturing process in the corresponding documentation.

Deadline tracking: Responsible for ensuring that ordered products are delivered on time.

Problem resolution: Identify and resolve problems efficiently.

Supplies management: Responsible for handling supplies (inventory, quotations, purchase orders, and storage).

Team work: Coordinate work with suppliers and clients.

Achievements: Organize manufacturing process following good laboratory practices.

Project Coordinator

FONDECYT 11130120 "SCLEROSTIN MODULATED MESENCHYMAL STEM CELL DERIVED CHONDROCYTES FACILITATES CARTILAGE REPAIR", Dr. Facundo las Heras, Clínica las Condes.

Jan. 2015 - Oct. 2016

Essential Functions: Coordinate and execution of FONDECYT project.

Regulatory requirements: Follow the rules of the "Fondecyt Initiation" contest for reporting results and reporting the use of funds.

Document management: creating results reports, protocols for experiments development and writing papers.

Data Management: recording experimental results. Bio-statistical analysis of experiments using GraphPad Prism.

Deadline tracking: Expense reports and results reports in a timely manner according to the proyect formulation.

Supplies management: Responsible for handling supplies (inventory, quotations, purchase orders and storage).

Funding management: Management and reporting of project funds usage to CORFO.

Team work: coordinate project execution with the principal investigator, study staff, collaborators and suppliers.

Achievements: Received a scholarship to attend the Till & McCulloch Meetings 2015 research congress on stem cell therapies in Canada. Co-authored the paper: Andrea Rojas et al. 2018. "Dickkopf-1 reduces hypertrophic changes in human chondrocytes derived from bone marrow stem cells." Gene, 687: 228-237.