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 14155 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**:
University 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 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.
lavoro temporaneo, Permanent e Professional Staffing, Ricerca e Selezione, Consulenza HR, Formazione, Outsourcing, supporto alla ricollocazione e attività complementari.
Siamo presenti in più di 30 Paesi in Europa, Asia e America con un team di oltre 6000 persone.
**I valori che ci contraddistinguono**:
attenzione, passione, apprendimento continuo e innovazione, collaborazione, sostenibilità, responsabilità.
Gi Group S.P.A. è autorizzata ad operare dal Ministero del Lavoro (Aut.
Min.
26/11/2004 PROT.
1101 - SG).