Especialista em Garantia de Qualidade

Saia na frente:

CANDIDATE-SE

Vaga ofertada por parceiro do Jobbol:
Key Responsibilities:Documentation Support Assist in the preparation, organization, and review of registration documents (such as technical documentation, labels, clinical data) to ensure compliance with regulatory requirements.Maintain version control and record management of registration files.Audit & Compliance Support internal/external audits by assisting in data collection, material preparation, and follow-up on corrective actions.Monitor compliance in the registration process and promptly report any issues found.Process Execution Assist in tracking the progress of registration applications and coordinate cross-departmental resources to solve problems.Implement quality assurance processes and standard operating procedures (SOPs).Regulatory Updates Keep track of industry regulatory developments, assist in collating updated content and communicate it to the team.Participate in regulatory training to enhance the compliance awareness of yourself and the team.Collaboration & Communication Support the RA team in registration submissions and assist in answering internal/external inquiries.Collaborate with R & D, production and other departments to ensure timely and accurate information transfer.
Qualifications:Education: Bachelor s degree in a science-related field (such as life sciences, chemistry, pharmacy), or equivalent.Experience: 0 - 2 years of experience in quality assurance or regulatory affairs.
Outstanding fresh graduates are also considered.Skills and Abilities: Familiarity with international regulatory frameworks (such as ICH, EMA, FDA), knowledge of Brazilian ANVISA regulations is preferred.Strong learning and execution abilities, attention to detail, and basic data analysis skills.Good communication skills, able to collaborate in a team and accept guidance.Proficiency in Microsoft Office, familiarity with document management systems is preferred.Language: Fluent in English (written/oral), Portuguese.Other Requirements:Have a rigorous work attitude and be able to efficiently complete multiple tasks under pressure.Have a strong interest in the regulatory affairs field and be willing to continuously learn and grow.