Clinical Quality Assurance Associate

Join to apply for the Clinical Quality Assurance Associate role at Kedrion Biopharma

Join to apply for the Clinical Quality Assurance Associate role at Kedrion Biopharma

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Department: Global Quality Systems and Compliance

Position Overview: We are seeking a motivated and dynamic individual to join our Global Quality Systems and Compliance. The candidate will collaborate to ensure that clinical trials sponsored by Kedrion are conducted in compliance with with current regulations and company quality standards.

Key Responsibilities:

• Collaborates in the implementation and maintenance of the Quality System for the clinical trials area.

• Participates in the process of managing changes that impact clinical trials.

• Takes part in the internal and external verification process in the clinical field as an Auditor.

• Contributes to identifying possible deviations from the GCP system and collaborates in the process of managing deviations and CAPAs.

• Participates in the analysis of trends in GCP processes.

• Collaborates in the review of Preclinical and Clinical Protocols and Reports.

• Participates in the process of preparing the Study Risk Assessment in the GCP area.

• Collaborates in the process of managing the training of personnel involved in activities related to clinical trials.

• Participates in the process of qualifying suppliers in the GCP area.

• Drafts and reviews Standard Operating Procedures for which the function is responsible.

• Carries out its activities in compliance with Best Practices and regulatory provisions applicable to the clinical trials sector.

• Collaborates in monitoring the production activities of experimental products (planning, packaging, storage and shipping) to ensure compliance with current regulations and company quality standards.

• Verifies that all documents managed by the Information System are aligned with the provisions of the document management procedure.

Requirements:

• Scientific Bachelor's degree
• Interest in the Quality and Compliance field.
• Good analytical skills, strong attention to detail, accuracy, flexibility.
• Excellent communication skills and the ability to work in a team.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Good knowledge of English (written and spoken).

This announcement is addressed to applicants of both sexes (L. 903/77 - D.Lgs n. 198/2006) and also to those belonging to Protected Categories (L.68/99).

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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