Description
IT Quality and Compliance Analyst/Turnhoutseweg, Beerse/5 Months Contract/64 EUR Per Hr
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 /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 work in line with Credo values, Janssen Supply Chain and J&J Supply Chain requirements.
12. The function holder will assist in the preparations of external and internal inspections related to overall quality and compliance.
13. The function holder will work in line with the Safety, Health and Environmental principles.
Non Technical Skills and Additional Details
(c)GMP and GDP standards. Pharmaceutical regulations. Medical Devices regulation. ISO Standards. Quality experience in pharmaceutical/medical device environment Knowledge or main IT tools, commonly used in the pharmaceutical sector (eg 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®. Core competencies required for this role:
Able to build strong relationship with internal and external customers
Team player
Confident, organized, persistent and assertive
Problem solver - structured & analytical way of working
A result oriented person with a pro-active problem solving attitude
Can work independent, knows the right priorities and escalate if needed.
Excellent verbal and written communication skills
Fluent in English, both verbal and written, other languages are a bonus
The Company
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.