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Clinical quality assurance associate

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Kedrion Biopharma
Pubblicato il 12 giugno
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PJoin to apply for the strongClinical Quality Assurance Associate /strong role at strongKedrion Biopharma /strong /ppJoin to apply for the strongClinical Quality Assurance Associate /strong role at strongKedrion Biopharma /strong /ppGet AI-powered advice on this job and more exclusive features. /ppstrongDepartment: /strong Global Quality Systems and Compliance /ppstrongPosition Overview: /strong 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. /ppstrongKey Responsibilities: /strong /pp• Collaborates in the implementation and maintenance of the Quality System for the clinical trials area. /pp• Participates in the process of managing changes that impact clinical trials. /pp• Takes part in the internal and external verification process in the clinical field as an Auditor. /pp• Contributes to identifying possible deviations from the GCP system and collaborates in the process of managing deviations and CAPAs. /pp• Participates in the analysis of trends in GCP processes. /pp• Collaborates in the review of Preclinical and Clinical Protocols and Reports. /pp• Participates in the process of preparing the Study Risk Assessment in the GCP area. /pp• Collaborates in the process of managing the training of personnel involved in activities related to clinical trials. /pp• Participates in the process of qualifying suppliers in the GCP area. /pp• Drafts and reviews Standard Operating Procedures for which the function is responsible. /pp• Carries out its activities in compliance with Best Practices and regulatory provisions applicable to the clinical trials sector. /pp• Collaborates in monitoring the production activities of experimental products (planning, packaging, storage and shipping) to ensure compliance with current regulations and company quality standards. /pp• Verifies that all documents managed by the Information System are aligned with the provisions of the document management procedure. /ppstrongRequirements: /strong /pulliScientific Bachelor's degree /liliInterest in the Quality and Compliance field. /liliGood analytical skills, strong attention to detail, accuracy, flexibility. /liliExcellent communication skills and the ability to work in a team. /liliProficiency in Microsoft Office (Word, Excel, PowerPoint). /liliGood knowledge of English (written and spoken). /li /ulpThis 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). /ph3Seniority level /h3ullih3Seniority level /h3Entry level /li /ulh3Employment type /h3ullih3Employment type /h3Full-time /li /ulh3Job function /h3ullih3Job function /h3Quality Assurance /lilih3Industries /h3Pharmaceutical Manufacturing /li /ulpReferrals increase your chances of interviewing at Kedrion Biopharma by 2x /ph3Sign in to set job alerts for “Quality Assurance Associate” roles. /h3pWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. /p #J-18808-Ljbffr

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