GCP QUALITY ASSURANCE SPECIALIST

HiRevo LifeScience is currently looking for a  GCP Quality Assurance.
Our client is an Italian pharmaceutical company with more than 135 years of history.
The contest.
The function is part of the Quality team of the Global Medical Department, reporting to the Global QA Manager.
The role.
This role will support the implementation and maintenance of the Quality System for the management of Clinical Studies on Drugs and Medical Devices.
It provides oversight to the clinical trials management from a quality standpoint in order to ensure compliance to Good Clinical Practices, ISO and applicable Regulatory Requirements You will be responsible for.
Authoring and reviewing Procedures and Templates for study related activities, in collaboration with the involved departments Delivering Quality Assurance Training courses on new/revised Processes and Regulations, relevant to GCP and Clinical Trials Management Supporting the execution of the audits as Co-Auditor to internal processes, Trial Master File, investigational site and vendors.
Managing the Audit Reporting and CAPA Plan review till completion of all corrective actions Escalate and support the resolution of compliance issues Support the management of Non-conformities and CAPA plans Ensuring the review of key clinical trial documents from a Compliance standpoínt Ensuring, the Quality support to other Affiliates and Companies as per inter-company agreements Support Health Authorities inspections About you.
Master's Degree in a science related field Good knowledge of drug development, investigational medicinal products regulations and clinical operation processes Knowledge of GCP and clinical research Fluency in English (level C1/C2) and in Italian Analytical skills Communication skills Planning and organizational skills Team working Adaptability and flexibility Location.
Florence The company will offer an initial fixed-term contract (12 months) CCNL Chimico Farmaceutico.
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è autorizzata ad operare dal Ministero del Lavoro (Aut.
Min.
PROT.
- SG).
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gs.
n.
e ss.
m.
i.
e dei Decreti Legislativi n.
215 e n.
216 del sulle parità di trattamento.
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