04 set - Barga
Altro
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 Get AI-powered advice on this job and more exclusive features. 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 Referrals increase your chances of interviewing at Kedrion Biopharma by 2x Sign in to set job alerts for "Quality Assurance Associate" roles.
We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
04 set - Padova
immobiliare.scorpion
04 set - Ceglie Messapica
laboanna soc. coop.
04 set - Afragola
TITANIUM
04 set - Vicenza
Cooperativa Sociale Società Cooperativa Sociale