Senior GCP Quality Management Specialist
Categorie: Clinical trials
Novellas Healthcare is searching for a Senior GCP Quality Management Specialist.
You have knowledge op GCP and experience in Quality Management?
Your purpose in this position: set-up, implement and follow up the implementation and maintenance of the Quality Management System in compliance with requirement of their respective GxP area (GCP).
You will be responsible:
- to set-up and maintain the quality management system in accordance with internal and external (inter)national standards and guidelines
- to perform a QA review on project documentation
- to organize and follow-up the required trainings
- for the operational quality support of projects, incorporating the risk based approach
- for the planning and timely execution of Quality Management process improvements and timely implementation of new or updated procedures
- to perform internal audits to verify the compliance of the Quality Management System of the client. Guarantee the follow-up of the corrective and preventive actions
- Master or PhD in a relevant field of life science
- Knowledge of applicable GxP regulated environment (GCP)
- 15 years of experience in the pharmaceutical and/ or Biotechnology industry
- Experience with document control systems
- Knowledge of health authority’s guidelines and regulations regarding GCP
- Good knowledge of MS Office
- Very good knowledge of English (written and spoken)
Novellas Healthcare offers you a job in a dynamic work environment and a competitive remuneration package according to your experience.
Novellas Healthcare is a company with over 10 years of experience in people-related services for the healthcare sector. Our goal is to maximize people’s careers in healthcare, and our customer’s human capital. We provide Permanent and Flexible Staffing Solutions, Training & Coaching and Patient Programs.Back to overview