GMP Quality Management Specialist - Belgium
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.
- 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
- 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)