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QA EDN QMS Associate
Eingestellt von Sentinel IT LLP
Gesuchte Skills: Client, Support
Projektbeschreibung
QA EDN QMS Associate
Leading global pharmaceutical client require a QA EDN QMS Associate for long-term contract based Belgium.
Overview:
* The function holder is responsible to manage the local quality systems branch of EDN under supervision of the EDN Quality Manager.
* The function holder will participate in the implementation of various projects requiring a thorough Quality and Compliance assessment.
* The function holder will assist the Site Quality Manager in implementing and maintaining a Pharmaceutical Quality System as defined in: Article 47 of Directive 2001/83/EC and laid down in Eudralex Volume 4 GMP guidelines; in both GMP and GDP requirements and in ISO standards.
Responsibilities:
1. Function holder will be responsible for the review and improvement of the quality management system and will coordinate the QS activities.
2. Function holder will coordinate the activities of inspections readiness and ISO certification if required.
3. Function holder will review and improve processes of the QMS, ensure that KPIs are in place.
4. Function holder will collaborate for the definition of Quality objectives and for the development of a quality mindset.
5. Function holder will collaborate and will provide input for Quality Improvement Program meetings and Quality Management Reviews.
6. Function holder will participate in the development of new project implementations with a specific QA & Regulatory focus.
7. The function holder will take the role of training coordinator in order review training curricula, will create training materials and will develop/train the EDN personnel in order to ensure that operational personnel has an appropriate understanding of the Good Manufacturing Practices and Good Distribution Practices.
8. The function holder will take the role of Business administrator for the document Management system
9. The function holder will conduct and assist internal audits of EDN departments. The goal of these self-inspections is to perform an in-depth review of the operation in view of the applicable cGMP and GDP regulations.
10. To support CLS-EMEA QMS owner on the creation, the update and audit of shared processes
11. The function holder will assist in the preparations of external and internal inspections related to overall quality and compliance.
12. The function holder will work in line with the Safety, Health and Environmental principles.
Please apply now for more details!
Leading global pharmaceutical client require a QA EDN QMS Associate for long-term contract based Belgium.
Overview:
* The function holder is responsible to manage the local quality systems branch of EDN under supervision of the EDN Quality Manager.
* The function holder will participate in the implementation of various projects requiring a thorough Quality and Compliance assessment.
* The function holder will assist the Site Quality Manager in implementing and maintaining a Pharmaceutical Quality System as defined in: Article 47 of Directive 2001/83/EC and laid down in Eudralex Volume 4 GMP guidelines; in both GMP and GDP requirements and in ISO standards.
Responsibilities:
1. Function holder will be responsible for the review and improvement of the quality management system and will coordinate the QS activities.
2. Function holder will coordinate the activities of inspections readiness and ISO certification if required.
3. Function holder will review and improve processes of the QMS, ensure that KPIs are in place.
4. Function holder will collaborate for the definition of Quality objectives and for the development of a quality mindset.
5. Function holder will collaborate and will provide input for Quality Improvement Program meetings and Quality Management Reviews.
6. Function holder will participate in the development of new project implementations with a specific QA & Regulatory focus.
7. The function holder will take the role of training coordinator in order review training curricula, will create training materials and will develop/train the EDN personnel in order to ensure that operational personnel has an appropriate understanding of the Good Manufacturing Practices and Good Distribution Practices.
8. The function holder will take the role of Business administrator for the document Management system
9. The function holder will conduct and assist internal audits of EDN departments. The goal of these self-inspections is to perform an in-depth review of the operation in view of the applicable cGMP and GDP regulations.
10. To support CLS-EMEA QMS owner on the creation, the update and audit of shared processes
11. The function holder will assist in the preparations of external and internal inspections related to overall quality and compliance.
12. The function holder will work in line with the Safety, Health and Environmental principles.
Please apply now for more details!
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges