Qualified Person/responsible Person - Braine-l'Alleud, België - BAXTER

BAXTER

Geverifieerd bedrijf

Braine-l'Alleud, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world.

You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Your Role at Baxter

This is where your motivation addresses challenges

Your Team at Baxter
As a Qualified Person/Responsible Person, you will report directly to the CQA/RA Manager Benelux. The Quality function values both working together as a team and independently. We draw energy from working in collaboration with internal and external stakeholders.

As the company evolves, so does the way our team approaches work as it strives to create new development opportunities and new ways of working.

Baxter plans to spin off the Kidney Care Global Business Segment from Baxter to become an independent, publicly traded separate company (currently referred to as Kidney Co. until the company launches).

What you will be doing:

Authorized to act as the Responsible Person (RP) for the two Benelux local entities (one in Belgium, one in The Netherlands) and responsible for maintenance of related regulatory licenses (WDA, medical device notification) and as Qualified Person (QP) for the Belgian entity (MIA).
Responsible for ensuring outsourced storage and distribution activities are in line with European and local legal requirements, and Corporate Quality Systems implementation in the Benelux local entities to ensure establishment and maintenance of required licenses (e.g. WDA, MIA, ISO 9001 and ISO 13485 certifications).
Act as the Post Market Surveillance and local contact person for medical devices.
Responsible for Quality Support to local business initiatives in collaboration with Quality Operations.
Ensuring that appropriate contacts with country Regulatory Affairs, Pharmacovigilance, thirdparty logistics (3PL) for Warehouse & Distribution (W&D), transporters and Businesses are maintained.

What you will bring:

Master's degree in Pharmaceutical Sciences and/or Advanced master's in industrial pharmacy
Certified QP from Belgian FAMHP
Proficiency in Dutch, French and English
Office basic knowledge required
Trackwise, JDE, ERP system particular knowledge required
Knowledge of ISO, GDP, and GMP standards and applicable quality systems in area of responsibility
Product and process validation methodology
Knowledge of Medical Industry Processes
IT functional knowledge (ERP systems, data management systems)

Reasonable Accommodations

Recruitment Fraud Notice

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To learn how you can protect yourself, review our Recruitment Fraud Notice.

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