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Job Description Summary

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare

has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

In this role, you will hold full QA responsibility as designated Responsible Person for the wholesale distribution activities of GE Healthcare BV, under a Wholesale Dealer’s Authorisation, and support of GDP activities for GE Healthcare BV Manufactured products.

Key Responsibilities include:

· Quality Management System – Good Distribution Practices (GDP) – working with the Manufacturing site QMS, to develop, implement and maintain procedures relating to the wholesale distribution activities of distributed products and supporting activities related to distribution of manufactured products

· Inbound release of Contrast Media and cold kits to the 3PL warehouses (in Germany and Netherlands)

· Partnership with the 3PL warehouses in Germany and Netherlands

· RP responsibilities for warehouse storage and outbound deliveries of products to end customers in Belgium, Luxembourg and the Netherlands

· Management of outsourced activities – 3PL, local carriers, including supplier qualification, audits and Quality and Technical Agreements

· Quality Risk Management of the wholesale distribution operation

· Assist in developing and delivering training for functions supporting GDP activities

· Oversight of customer qualification process

· Liaison with regulatory authorities regarding activities related to the wholesale distribution activities of distributed products under the WDA

· RP responsibilities for returns (final disposition of returned, rejected, recalled or falsified products)

· Point of contact for Customer Complaints related to distribution

· Contact for Product Recalls where required

· Perform Self-inspection and Internal Audit

· Hosting Quality System Audits (internal and external)

· Change Management within the wholesale distribution operation

· Responsibility for Deviations, Investigations, Corrective Actions relating to the wholesale distribution operation and QA support for other GDP activities

· Quality System Monitoring and Review for effectiveness and implementation of continuous improvement programs

· Availability to be constantly contactable as per the EU GDP Guidelines

· Liaison with the Manufacturing site to support local route risk assessments and route qualifications

Required Qualifications:

• You bring a degree in pharmacy, human sciences, veterinary medicine, chemistry, biology (article 95 .2 of the Royal Decree of 14 December 2006, or assessed equivalence)

• You are eligible to be designated a Responsible Person on a Wholesale Dealer’s Authorisation in Belgium, Luxembourg and Netherlands

• Business fluent in Dutch and English (written and oral), additional languages advantageous

• You bring proven experience in the pharmaceutical industry, preferably in a Distribution or Manufacturing environment

Desired Characteristics:

• A prior designation as a Responsible Person on a Wholesale Dealer’s Authorisation is preferred

• Experience in dealing with competent authorities

• Problem solving skills

• Experience in auditing (as auditor and auditee) High degree of self-motivation and self-responsibility

• Influencing abilities and working within a cross-functional and multi-national team

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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Additional Information

Relocation Assistance Provided: No