Laís Lopes Email & Phone Number

Berlin, De

Rio De Janeiro, Rio De Janeiro, Brasil

- Manage quality deviations of all complexities throughout the processing stages of Vaccines, Biopharmaceuticals and Diagnostic Kits, focusing on preventing recurrences and ensuring compliance with internal and external standards.-Conduct investigations of technical complaints.-Act as a facilitator in regulatory inspections, audits of technology transfer partners and certification bodies.-Review internal audit plans and reports and act as internal auditor.- Carry out self-inspections to promote a quality culture.- Monitor the implementation of CAPA plans.- Manage training on deviations and use of quality tools.- Participate in impact assessment committees and risk management and change control strategy meetings.- Disclose GMP guidelines to ensure data reliability and integrity.

Rio De Janeiro, Rio De Janeiro, Brasil

- Manage quality deviations and CAPA plans for diagnostic kits for human and veterinary use.- Evaluate and investigate technical complaints about diagnostic kits for human and veterinary use.- Contribute to the continuous improvement of testing and quality processes.

Rio De Janeiro, Rio De Janeiro, Brasil

- Develop and review quality guideline programs, defining activities, responsibilities and criteria;- Compile and evaluate documentation to release batches and issue certificates of conformity for the finished product;- Manage deviations, change control and CAPA plans classified as major and critical.- Develop and review validation plans for computerized systems such as SAP and participate in project meetings.- Prepare product quality review report (PQR);- Act as a risk management specialist;- Monitor regulatory inspections, interacting with auditors and ensuring quick fulfillment of requests.- Manage inspection and audit findings, monitoring the implementation of CAPA plans.- Participate in the development of new products;- Conduct multidisciplinary meetings to resolve quality problems and provide training on quality programs and policies.

Rio De Janeiro E Região, Brasil

- Develop and review standard operating procedures (SOPs), work instructions and analysis methods for raw materials and products.- Manage deviations, change control and CAPA plans classified as minor.- Assist in the development of risk management strategies.- Validate electronic spreadsheets.- Monitor regulatory inspections and audits, prioritizing requests for documentation and evidence.- Send pre-qualification protocols to suppliers and prepare annual product review reports.- Support in the registration and renewal process of medical devices and provide training on good manufacturing practices.- Assist in renewing company licenses.

Penha Circular, Rio De Janeiro

- Develop/review standard operating procedures and work instructions;- Reconcile production dossier of batches;- Assist in the processes of regulatory inspections and audits;- Review and monitor preventive maintenance plans for equipment, periodic calibration of instruments, pest control and waste disposal and monitor the execution of services, as well as update control spreadsheets;- Carry out periodic inspections in manufacturing areas in order to verify their compliance with good manufacturing practices;- Monitor and update the list of training carried out in the unit.

Rio De Janeiro E Região, Brasil