Sofía Morales Email & Phone Number

Quality Management System based on BRC, ISO 9001 & GMP standards.

Argentina

Providing advice on investments, medium and long-term savings and financial protection for individuals, families and companies. I provide my clients with personalized advice according to their needs and objectives at all stages of their life, so that they obtain independence and economic security.

Development, implementation, communication and maintenance of a Quality plan to sustain the Quality system and polices of the site in Argentina, in compliance with the quality system requirements and the current local regulation. Definition of Quality processes and procedures, through the effective management of controlled documents.Issue of Quality Assurance procedures, when required for GMP compliance. Support to Operation procedures. Internal audits as head auditor, including the issuance of reports. External audits programs, audits of external services vendors, as part of the process of supplier qualification. Regulatory inspections and client audits reception, response to audit / inspection reports.GMP / GDP / QA trainer. Receptions verifications of products and materials for storage and distribution and anpproval of secondary packaging processes.Monitoring of non-conformities, complaints, CAPAs, identifying and implementing quality improvement.Review and approval of qualification and validation processes.

Provincia De Buenos Aires, Argentina

Validation manufacturing processes and secondary pakaging validation. Qualification of GxP equipments, areas, services. Evaluation of PPR in validation items for all the products.

Buenos Aires, Provincia De Buenos Aires, Argentina

Quality expert in the validation of computarized systems.

Garín, Buenos Aires

Validation manufacturing processes and secondary pakaging validation. Media Fill. Cleaning Validation. Qualification of GxP equipments, areas, services.

Development, implementation, communication and maintenance of a Quality plan to sustain the Quality system and polices of the site in Argentina, in compliance with the quality system requirements and the current local regulation.Definition of Quality processes and procedures, through the effective management of controlled documents.Issue of Quality Assurance procedures, when required for GMP compliance. Support to Operation procedures.Review and approval of qualification of equipments, areas and services and validation processes.

Support to EHS department as trainee.