Quality Specialist Ii - Verona, Italia - Evotec

Evotec
Evotec
Azienda verificata
Verona, Italia

1 mese fa

Piero Bianchi

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee
Descrizione

Aptuit, an Evotec company, is a worldwide Contract Research Organization, collaborating with all the major Pharma and Biotech companies in support of various drug discovery and development projects including Phase I clinical trials.


To efficiently support ongoing activities and needs, we are looking for a highly motivated Quality Assurance Specialist with knowledge and experience in Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) to work in GLP/GCP Quality Assurance team.


This is a position that offers a multitude of options for personal and professional development in a fast changing environment focus on new therapies, digital transformation and accelerated technologies changes.


Key Responsibilities:

  • Review study plans, reports and data (electronic and paper)
  • Perform internal inspections
  • Provide support on the digital transformation projects including use of data analytics
  • Assist the collection and monitor for trends and the effectiveness of the GLP/GCP quality management systems including developing and producing KPI's and Quality Metrics
  • Facilitate or perform risk assessment and Root Cause Analysis as required
  • Provide quality advise and support to internal departments and related projects

Requirements:


  • Degree or PhD in Science fields (Pharmaceutical Technology and Chemistry, Biomedical Engineering, Bioinformatics, Biotechnology or equivalent)
  • At least 23 years experience in a Quality Assurance role
  • Knowledge of Bioinformatics and statistics
  • Knowledge of Risk Management
  • Good written and spoken English is essential
  • Good problem solving attitude
  • Effective communication, both verbally and in written form, to Sponsors as well as members of internal teams
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