Quality Operations Coordinator – GMP & Batch Records

Takeda

Rieti

In loco

EUR 31.000 - 43.000

Tempo pieno

5 giorni fa
Candidati tra i primi
Generatore di candidature

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Descrizione del lavoro

Takeda in Rieti, Italy, is seeking a Quality Oversight professional to verify GMP compliance and manage batch records in collaboration with Production. You will lead CAPAs, review procedures, and ensure data integrity across manufacturing systems.

The role requires a scientific degree, strong English, and proven problem-solving and leadership skills. It offers a full-time, on-site position with a base salary range of €31,200–€42,900 and the opportunity to contribute to continuous improvement in

Competenze

  • Degree in scientific discipline or approved knowledge of manufacturing processes.
  • Good command of English.
  • Excellent knowledge of manufacturing process and quality principles.

Mansioni

  • Review and ensure execution of quality batch record review per SOPs and regulations.
  • Open and manage events identified during batch review and reported by operators.
  • Review production procedures and master batch records.
  • Identify and implement CAPAs to improve GMP compliance in production areas.
  • Collaborate with Production to resolve compliance gaps and ensure traceability of GMP documentation.
  • Lead/execute projects to deepen knowledge of production activities.
  • Maintain GMP documentation management including archiving and data collection.
  • Prepare equipment cleaning samples and verify plasma receipt requirements.

Conoscenze

English proficiency
Analytical skills
Communication & leadership
Technical writing & presentation

Formazione

Degree in scientific discipline

Descrizione del lavoro

Takeda in Rieti, Italy, is seeking a Quality Oversight professional to verify GMP compliance and manage batch records in collaboration with Production. You will lead CAPAs, review procedures, and ensure data integrity across manufacturing systems.

The role requires a scientific degree, strong English, and proven problem-solving and leadership skills. It offers a full-time, on-site position with a base salary range of €31,200–€42,900 and the opportunity to contribute to continuous improvement in

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