Description
Proteus Europe is searching for a Compliance Analyst with experience in the pharmaceutical Industry, avaialble to work for a short term contract for one of our clients in Belgium.Our Client :-
Are a globally respected consultancy company who operate at the highest levels of service and successful delivery. They have a track record for delivering projects on time with customer satisfaction as their first priority. They set high standards and as such working with them also reflects on your high standards of service and programming ability.
Your New role :-
The function holder is responsible to manage the local quality systems branch of EDN under supervision of the EDN Quality Manager.
o The function holder will participate in the implementation of various projects requiring a thorough Quality and Compliance assessment.
o 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 and 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 JandJ 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.
On-site work
Your Skills and experience :-
Essential Skills :-
(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 (e.g. TrackWise®, , SAP). Experience as quality external and internal auditor. Presentation and 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 and 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
Proteus Europe operates in partnership with our candidates by building strong and lasting
relationships at all levels.
If you apply for this role, we will:
- Contact you within one week to discuss your current situation and suitability for this role.
- Keep searching for other suitable positions should this role not be right for you.
- Keep you informed at every stage of the recruitment process.
- Actively follow up with our client on your behalf to gain useful feedback throughout the
process.
If you are looking for a new role, but this role isn't quite right for you, please contact us in
confidence for a discussion about how we can help you.