Quality coordinator – Paulínia/SP

Responsabilidades

• Responsible for ensuring the implementation of the Quality Management System within the R&D department – Brazil, with direct interaction with Corporate.
• Establish, together with the Bio & Pharma Development area, quality systems across departments, laboratories, and partners, in compliance with empresa corporate standards.
• Implement internal control processes and ensure the reliability of information.
• Execute internal audit programs, aligned with Corporate, for systems and procedures related to quality, aiming to identify improvement opportunities in processes, systems, and activities.
• Implement and organize the R&D Quality Assurance function across the Brazil campuses (Paulínia, Juatuba, and Campinas).
• Comply with the Global Quality Assurance standards defined for the development and registration of vaccines and pharmaceuticals.
• Ensure compliance of laboratory equipment and systems used by R&D.

Requisitos

• Bachelor’s degree in Chemistry, Biochemistry, Pharmacy, or Veterinary Medicine.
• Advanced/Fluent English.
• Knowledge and strong understanding of Quality Management Systems and the development of new products and laboratories.
• Knowledge of process validation, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP).
• Knowledge of the stages of research and development of new biological and pharmaceutical products.
• Knowledge of MAPA guidelines and other key regulations (VICH, EMA, ANVISA).

Marcado como: ANVISA, BPF, Medicamentos Veterinários, Pesquisa e Desenvolvimento, Qualidade, Vacinas