Date:  Jul 11, 2024
Location: 

Villepinte, FR

Job Type:  Long-term/regular

 CHARGE AQ DISTRIB. EMEA M/F (29310)

 

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

 

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

 

Achieve, Cooperate, Care and Innovate are the values ​​that we share and practice on a daily basis.

 

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

 

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

 

 

Serving as the Quality Contact Point for internal stakeholders and external EMEA partners, this position will ensure effective operational and GDP quality compliance across the EMEA distribution network.

 

  1. Quality Management System (QMS)
  • Support the development, implementation and maintenance of a QMS in line with Good Distribution Practices to drive standardization of processes, documentation and equipment across Supply Chain and DCs in EMEA region.
  • Initiate, write, issue & update Guerbet SOPs, Work Instruction (WIs), Records, Policies & Guidelines; ensure that these documents are in line with GDP Guidelines and current regulatory requirements.
  • Apply a Quality Risk Management approach in addressing quality issues detected by the Third-Party Logistics and local affiliates across EMEA; utilize risk management tools to identify and mitigate quality and compliance risks.
  • Participate in quality improvements projects and apply GDP Change control processes.
  • Establish and monitor Quality goals and metrics.
  • Assess and Monitor Third-Parties quality performance.
  • Perform qualification of processes related to GDP/GMP.
  • Support and deliver training related to quality.
  • Support internal & external audits

 

  1. Overall Quality Responsibility for Distribution Center (DCs) and transport 
    • Manage all related quality processes related to DCs (e.g. return, temperature-controlled monitoring and risk assessment…) or transport (damaged, temperature excursion …)
    • Manage distribution non-conformances and customer distribution complaints; track their closure in a timely manner.
    • Define and assure that the shipping lanes are appropriate and qualified to ensure the quality and integrity of the distributed products
  • Establish Shipping Qualification protocol and report
  • Manage the deviations observed during the shipping qualification
    • Support DC and transporter certification process
  • Support the establishment of the EMEA Audit Master Plan
  • Audit and Support audit of EMEA DCs and transporters
  • Update the Quality Agreements with the EMEA Third Parties and DCs
  • Perform Risk Assessment when requested
    • Support GDP auditor certification
    • Jointly with DCs’ Managers:
  • Set long term Quality Plans, priorities and targets and act on deviations from targets,
  • Monitor and review the DCs’ Quality performance and act on deviations / hot spots and opportunities.
  • Ensure the local transport delegated to the DC is correctly handled and certified

Prepare and deliver Quality GDP Training

 

 

Education Background :

  • Pharmacist with proven knowledge of Pharma GMPs and/or GDP, Medical Device regulations, ISO and other international standards
  • Knowledge and skills typically acquired through at least 3 years Quality Assurance.1 year of experience in Pharmaceutical Distribution would be a plus.

Skills & Qualifications

    • Understanding of different cultures, networking approach & excellent ability to guide, coach and mentor multifunctional departments.
    • Experience in developing quality management plans; ability to write reports and required documentations; knowledge of theories, tools and practices in quality improvement & change management
    • Ability to make sound decisions about scheduling and managing priorities; excellent verbal and written communication skills with courtesy and tact. 
    • Flexibility, strong organizational & Presentation skills, High personal integrity
    • Fluent written and spoken English matched with good communication and training skills.
    • Strong analytical and systemic problem-solving skills.
    • Demonstrated auditing and corrective action proficiency

Experience in computer applications such as SAP, Minitab, Microsoft Word, Excel, Access and Power Point.

 

Reason to join US

Much more than a Competitive salary,


We offer continued personal development. When you join Guerbet, you :

  • Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, 
  • Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
  • Are joining a company where we value diversity of talents coming from various horizon.

 

We # Innovate # Cooperate # Care #Achieve at Guerbet. 

 

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

 

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or you can also call this number +19843443717