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GMP Quality Management Specialist Ghent Belgium,  

Ablynx (company)


Posted on : 15 July 2017

Project Description

Purpose of the 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/ GMP /GLP) and/or R&D area.

 

Key Responsibilities:

  • Responsible to set-up and maintain the quality management system in accordance with internal and external (inter)national standards and guidelines.
  • Responsible to support the definition, set-up and implementation, in collaboration with the operational staff, procedures to assure development and commercialization activities are conducted in accordance with internal and external (inter)national standards and guidelines.
  • Responsible for the operational quality support of projects, incorporating the risk based approach.
  • Responsible for the planning and timely execution of Quality Management process improvements and timely implementation of new or updated procedures 
  • Responsible to perform a QA review on project documentation.
  • Responsible to organize and follow-up the required trainings.
  • Responsible to perform internal audits to verify the compliance of the Ablynx Quality Management System. Guarantee the follow-up of the corrective and preventive actions.
  • Responsible for auditing third parties to assure that processes used and/ or data generated by these third parties meet all quality standards. Establish written agreement with third parties defining the quality requirements. Guarantee the follow-up of the corrective action/ preventive actions and continuous evaluation of third parties.
  • Responsible to provide support in preparation of and act as spokesperson during regulatory inspections

 

Skills, Expertise and Contribution:

  • Familiar with regulated environment (pharmaceutical) and inspections
  • Knowledge of validation principles applicable to the pharmaceutical industry
  • Impact of Decisions: very good communication and negotiation skills (auditor), proactive
  • Organizational skills: good organization skill to be able to follow multiple studies and audits
  • Sufficient scientific knowledge allowing to understand the test procedures although no technical skill is required

Minimum Qualifications:

  • Expected educational qualifications: Master or PhD in a relevant field of life science with knowledge of applicable GxP regulated environment
  • Expected experience:
    • 5-10 years of experience in the pharmaceutical and/ or Biotechnology industry
    • Experience with document control systems
    • Knowledge of health authority’s guidelines and regulations regarding GxP/ R&D
    • Good knowledge of MS Office
    • Very good knowledge of English (written and spoken)

Locations

Ghent Belgium

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