Quality Systems Associate-00000RA3
Description
The Quality Systems Associate is responsible to manage the local quality systems branch of the DC La Louvière under supervision of the site quality head.
He/she will participate in the implementation of various projects requiring a thorough Quality and Compliance assessment.
He/she assists the site quality head and Qualified Person in implementing and maintaining a Pharmaceutical Quality System
Responsibilities:
- Review and improvement of the quality management system and will coordinate the QS activities.
- Coordinate the activities of inspection readiness and ISO 13485 certification
- Review and improve processes of the QMS, ensure that KPIs are in place
- Collaborate for definition of Quality objectives and for developing quality mindset
- Collaborate and provide input for Quality Improvement Program meetings and Quality Management Reviews
- Participate in the development of new project implementations with a specific QA & Regulatory focus. The requested input may vary from:
- Defining a legal framework for new implementations (a.o. Medical devices,...)
- Creation of technical agreements, adapting WIs and SOPs
- Integration of new franchises, types of products (biologicals,...)
- Review training curricula, create training materials and will develop / train DC La Louvière personnel in order to ensure that operational personnel has an appropriate understanding of the Good Manufacturing Practices and Good Distribution Practices.
- Assist in internal audits of DC La Louvière 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.
- Work in line with Credo values, Janssen Supply Chain and J&J Supply Chain requirements
- assist in the preparations of external and internal inspections related to overall quality and compliance
- Work in line with the Safety, Health and Environmental principles
Qualifications
- Masters Degree in Life Sciences, Bio Engineer or Industrial Pharmacist with at least 5 years of Quality Assurance experience
- Experience in implementation or improvement of Pharmaceutical and Medical Quality Systems is a strong asset.
-
Experience in pharma, Audit, GDP, distribution is an asset
- Knowledge or main IT tools, commonly used in the pharmaceutical sector (e.g. TrackWise®, eDMS, LMS, SAP)
- Presentation & training skills
- Fluent in French and English
STEP-BE
s
Primary Location:Europe/Middle East/Africa-Belgium-Hainaut-La Louvière
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: Quality Assurance
Description
The Quality Systems Associate is responsible to manage the local quality systems branch of the DC La Louvière under supervision of the site quality head.
He/she will participate in the implementation of various projects requiring a thorough Quality and Compliance assessment.
He/she assists the site quality head and Qualified Person in implementing and maintaining a Pharmaceutical Quality System
Responsibilities:
- Review and improvement of the quality management system and will coordinate the QS activities.
- Coordinate the activities of inspection readiness and ISO 13485 certification
- Review and improve processes of the QMS, ensure that KPIs are in place
- Collaborate for definition of Quality objectives and for developing quality mindset
- Collaborate and provide input for Quality Improvement Program meetings and Quality Management Reviews
- Participate in the development of new project implementations with a specific QA & Regulatory focus. The requested input may vary from:
- Defining a legal framework for new implementations (a.o. Medical devices,...)
- Creation of technical agreements, adapting WIs and SOPs
- Integration of new franchises, types of products (biologicals,...)
- Review training curricula, create training materials and will develop / train DC La Louvière personnel in order to ensure that operational personnel has an appropriate understanding of the Good Manufacturing Practices and Good Distribution Practices.
- Assist in internal audits of DC La Louvière 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.
- Work in line with Credo values, Janssen Supply Chain and J&J Supply Chain requirements
- assist in the preparations of external and internal inspections related to overall quality and compliance
- Work in line with the Safety, Health and Environmental principles
Qualifications
- Masters Degree in Life Sciences, Bio Engineer or Industrial Pharmacist with at least 5 years of Quality Assurance experience
- Experience in implementation or improvement of Pharmaceutical and Medical Quality Systems is a strong asset.
-
Experience in pharma, Audit, GDP, distribution is an asset
- Knowledge or main IT tools, commonly used in the pharmaceutical sector (e.g. TrackWise®, eDMS, LMS, SAP)
- Presentation & training skills
- Fluent in French and English
STEP-BE
s
Primary Location:Europe/Middle East/Africa-Belgium-Hainaut-La Louvière
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: Quality Assurance