EDN Quality Management System Associate

Job description

Company Description

‘Caring for the world, one person at a time' ... inspires and unites the people of Johnson & Johnson . We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.
Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.

Overall purpose of the job

· The Quality Management Associate is responsible to manage the local quality systems branch of European Distribution Network (EDN) under supervision of the EDN Quality Manager.
· He/She will participate in the implementation of various projects requiring a thorough Quality and Compliance assessment.
· He/she 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.

Main tasks:

· The Quality Management Associate is responsible for the review and improvement of the quality management system and will coordinate the QS activities.
· You coordinate the activities of inspections readiness and ISO certification if required.
· You review and improve processes of the QMS, ensure that KPIs are in place.
· You collaborate for the definition of Quality objectives and for the development of a quality mindset.
· You collaborate and provide input for Quality Improvement Program meetings and Quality Management Reviews.
· You participate in the development of new project implementations with a specific QA & Regulatory focus.
· You 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.
· You take the role of Business administrator for the document Management system.
· You 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.
· You support CLS-EMEA QMS owner on the creation, the update and audit of shared processes.
· You work in line with Credo values, Janssen Supply Chain and J&J Supply Chain requirements.
· You assist in the preparations of external and internal inspections related to overall quality and compliance.
· You work in line with the Safety, Health and Environmental principles.

Desired profile

·  Bachelor/Master
·  Good knowledge of (c)GMP and GDP standards.
·  Good knowledge of Pharmaceutical regulations.
·  Good knowledge of Medical Devices regulation.
·  Good knowledgeISO Standards.
·  Quality experience in pharmaceutical/medical device environment
·  Knowledge of main IT tools, commonly used in the pharmaceutical sector (e.g. TrackWise®,..., SAP).
·  Experience as quality external and internal auditor.
·  Presentation & training skills
·  Incident and complaint Management System (TrackWise®).
·  Learning Management System (ComplianceWire).
·  Electronic Document Management System (Tru- Vault)
·  Microsoft Office application®.
·  English: full Professional proficiency

What's in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.

If you are interested in the position and match the above criteria, please apply online.
Inform your manager upfront.