QA Specialist I
2 semanas atrás
**Main responsibilities**
**Analista de Qualidade Assegurada**
- Ensure quality management, including strong focus on customers, motivation and involvement of senior management, approach to procedures and continuous improvement of processes and services;
- Attend internal and external audits, publish audit date to all employees and ensure that they are fully familiar with their specific instructions, policies and quality goals, as well as the company's quality mission;
- Implement programs to disseminate and improve good manufacturing practices;
- Interact with global quality processes, procedures and alignment of guidelines, as well as regulatory matters;
- Carry out qualification and approval of suppliers;
- Approve suppliers of critical materials;
- Ensure that critical quality activities are carried out as established;
- Ensure that critical deviations are investigated and corrective and preventive actions implemented;
- Approve the procedures, specifications and instructions that impact the quality of the pharmaceutical excipient;
- Approve a self-inspection program and ensure its execution;
- Approve the technical specifications for contracting outsourcing services related to the manufacturing and quality control of pharmaceutical excipients;
- Approve changes that affect the quality of pharmaceutical excipients;
- Ensure that complaints, returns and collections are documented and executed as established and, when necessary, corrective and preventive actions are implemented.
- Approve the training program and ensure that it is being carried out as planned;
- Approve the calibration and preventive maintenance program and ensure that they are being carried out as planned
- Complete documents and questionnaires requested by customers, as well as review customer specifications.
- Provide product information to internal and external customers in relation to national and international regulatory requirements in the area of additive regulations and related laws.
- Monitor discussions and publications of national and international legislation and facilitate interpretation when applicable to the organization.
- Review and/or develop technical specifications and other regulatory documents for raw materials and packaging.
- Completed Graduation in Food Engineering, Chemical Engineering, Chemistry or Science.
- Previous experience in the area, preferably in the food industry.
- Knowledge of Brazilian legislation, CODEX, Mercosul, FDA and the FSSC22000 certification standard.
- Advanced level English mandatory. Intermediate Spanish desirable.
- Interpersonal and communication skills, organizational and planning skills required to handle multiple tasks simultaneously.
**Importante**: 100% presencial em Jundiaí-SP, inglês avançado de uso diário com escrita e reuniões.
LI-LN1
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