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Moteur de recherche d'offres d'emploi GEODIS

Quality GDP Compliance Manager F/M


Détail de l'offre

Informations générales

Entité de rattachement

GEODIS est un opérateur de la chaîne logistique se classant parmi les plus grandes entreprises dans son domaine en Europe et dans le monde. Rattaché à SNCF Logistics, qui est elle-même une branche du Groupe SNCF, GEODIS est le leader du Transport et de la Logistique en France et se place au quatrième rang européen. Son rayonnement international s'appuie sur une présence directe dans 67 pays et un réseau mondial qui relie plus de 120 pays.

Pourquoi nous rejoindre ?

Le Transport et la Logistique sont aujourd'hui un secteur clé de l'économie mondiale. En tant qu'acteur international majeur du marché, GEODIS a pour objectif la satisfaction totale de l'ensemble de ses parties prenantes, à commencer par celle de ses collaborateurs. Ce sont plus de 39500 collaborateurs à travers le monde qui partagent les mêmes valeurs d'engagement, de passion, de solidarité, de confiance et d'innovation, piliers de la stratégie du Groupe.

Ce poste est également ouvert à toute personne reconnue travailleur handicapé  

Référence

2020-6276  

Description du poste

Type de contrat

CDI-Temps plein

Fonction

Fonctions Support - Business Excellence

Intitulé du poste

Quality GDP Compliance Manager F/M

Description de la mission

GEODIS is a worldwide company providing transportation services to the Pharmaceutical and Healthcare Industry and has a global, regional and country GDP management following EU/WHO GDP guidelines.
As Quality GDP Compliance Manager, you will be a part of the Cross-Business LoB Freight Forwarding with focus on the Global Pharma & Healthcare strategy. This will be a full time position, part of the Business Excellence (Quality Safety & Health and Environment) Team, reporting to the Freight Forwarding Business Excellence. This role will report to the Business Excellence Director of Freight Forwarding.
Key Activities / Accountabilities:

The Business Excellence – Global Quality GDP Compliance Manager shall:

• Support the Freight Forwarding organization to implement a robust and compliant worldwide GDP Quality Management System
• Coordinate and support implementation of industry-specific guidelines, rules and standards applicable to the Geodis Pharma & Healthcare business scope
• Monitor performance of the GDP Quality Management System and assess its effectiveness
• Promote process improvements and program improvements as necessary
• Coordinate and budget for Global GDP expenditures (i.e. training, certifications, supplies, etc.)
• Develop and launch a Pharma & Healthcare ‘Audit Program' and perform audits on global suppliers, in addition to hosting global and strategic customer audits and quality reviews
• Monitor GDP Regional and Country customers and suppliers audits advising as appropriate on performance requirements (LoB, Region, Countries)
• Perform Regional /Country GDP inspections or risk assessments and report performance as appropriate to Top Management (LoB, Region, Countries)
• Provide training where required to ensure all GEODIS staff involved in the distribution of medicinal product is competent to do so; maintain training records centrally and available to all interested parties
• Onboard Regional GDP Responsible Persons (new hires)
• Assess Regional GDP regulatory compliance level
• Advise country licensing and registration process, and support regions and countries with the application of activities and provisions in accordance with the wholesale distribution authorization (WDA) and adequate applicable company processes and procedures
• Manage the roll out of a global certification program i.e. CEIV, Certipharm, SGS, etc as applicable
• Support and customize content for global or strategic Pharma & Healthcare customer tenders
• Support Pharmaceutical and Healthcare Global or Strategic accounts implementation throughout the network
• Identify and mitigate risks of GDP non-compliance on a regional/country level
• Report on the status of network GDP risks and compliance to the Business Excellence Director
• Ensure relevant customer complaints are handled effectively, performing trend analysis and reporting that accordingly to required levels of the organization
• Approve final lane validations Global/Region

Profil du candidat

• Quality Management
• Bachelor or master's degree in Logistics, Pharmaceutical Sciences or equivalent
• Relevant experience related to the distribution of medicinal products and WHO/EU GDP and ISO Standards
• Fluent in English language: written and spoken

The individual should understand:
• The principles and guidelines of Good Manufacturing Practice and how GDP principles maintain product quality throughout the distribution chain
• The role of the Regulatory Agency in the licencing of medicines and the competent authority including the risk-based inspection process, the role of the enforcement group, and resulting actions that can be taken due to non-compliance
• Knowledge to requirements to obtain a ‘Wholesale Distribution Authorization (WDA)'
• Minimum 3-5 years' experience within a Pharmacy operational environment with key knowledge of a diverse pool of countries regulatory agencies
• Minimum 3-5 years' experience managing a program aligned to EU/WHO GDP Guidelines

• The role of the professional bodies or public health organisations that regulate supplying medicinal products to the public e.g. FAGG, FDA, MHRA, ANVISA, etc…
• The role of the United Nations in relation to the handling of controlled drugs
• The role of the Veterinary Medicines Directive in relation to veterinary medicines
• The role of the European Medicines Agency and use of EUDRAGMDP
• The role of World Health Organization - WHO
• The falsified Medicines Directive

Lieu de prise de service

Lieu de prise de service

Europe

Ville(s)

Europe

Critères candidat

Niveau d'études min. requis

INGENIEUR

Niveau d'expérience dans la fonction

Confirmé (5 à 10 ans d'expérience)

Langues

Anglais (Maitrise Courante)