Quality Specialist Ii - Glp/Gcp Verona

Quality Specialist Ii - Glp/Gcp
Verona
Veneto, Verona

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 2-3 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