Senior GCP Quality Management Specialist

Reference: VAC000915

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).

Description

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

Profile

  • 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)

Offer

Novellas Healthcare offers you a job in a dynamic work environment and a competitive remuneration package according to your experience.

Novellas Healthcare

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.

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