Spécialiste Qualité Supplier Management Cdd 12 - Dreux, France - IPSEN

IPSEN
IPSEN
Entreprise vérifiée
Dreux, France

il y a 2 semaines

Sophie Dupont

Posté par:

Sophie Dupont

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Description

Title:

Spécialiste Qualité Supplier Management CDD 12 mois


Company:

Ipsen PharmSciences SAS


Ipsen is a global biopharmaceutical group dedicated to improving lives and health outcomes through innovative medicines in Oncology, Neuroscience and Rare Disease.

We are committed to discovering new treatments in areas with high unmet medical needs and improving the quality of life for patients.

Research and development are key elements of our strategy, reflecting our commitment to improving patients' lives and health outcomes. Bolstered by a culture of collaboration & excellence, Ipsen offers a unique proposition to 5,700+ employees committed to society.


Within the Global Pharmaceutical Development organization located across 4 Sites (France, Ireland, UK and North America), you will actively contribute to the strategy of becoming a center of excellence in the development of toxins, small molecules and medical devices and strategical partner in the life cycle management of the established products.

Working transversally with the different departments of the Pharmaceutical Development:

  • Maintain and develop an effective and appropriate Quality systems to ensure that all suppliers, service providers and subcontractors used by and under the Pharmaceutical Development's responsibility are appropriately qualified prior to use in accordance with appropriate GMP, EHS regulations and Ipsen standards or ISO regulations.
  • Ensure the local deployment and sustainability of the global Pharmaceutical Development Quality Management System.

Core responsibilities

  • Ensure the implementation and sustainability of a common Quality Management System across Pharm Dev sites and global functions to align the best practices, optimize and support strategic development projects in term of vendor management.
  • Develop and promote the use of the supplier quality module in Quality Connect (eQMS) within the Pharm Dev organization, with the objective of managing the supplier qualification process and associated documentation in this tool.
  • To ensure the training of the supplier quality module and to write or update the necessary documentation (procedure, instruction).
  • Contribute to the QTA process.
  • Contribute to the supplier quality review, in particular for supplier risk assessment.

Second responsibilities

  • Provide support to the teams in the use of the Quality Connect tool: answering questions, improving user documents, training.
  • Participate in the continuous improvement of Quality processes.

QEEHS Responsibilities

  • Respect the applicable good practices (GMP, BPD, etc.), the Energy, Environment, Health and Safety rules through the procedures in force within the establishment.

CSR Responsibilities
Implement and propose actions to develop CSR within the framework of Ipsen's guidelines.


Education / Certifications:

  • Pharmacist, engineer, master in quality

Experience:

  • First experience in the pharmaceutical industry must have
  • 2 to 5 years of experience in Quality department

Languages:
-
English imperative in order to communicate with the English speaking staff of Pharm Dev


Key competencies:

  • Indepth knowledge of the Quality Management System.
  • Knowledge of European GMP and FDA cGMP including annexes 1 and 13 of GMP and BPD as well as Directive 93/42/EEC and ISO 1348
  • Ease and taste for IT tools
  • Autonomy in the management of its activities
  • Team spirit
  • Writing skills
  • Rigor
  • Initiativetaking
  • Dynamic
  • Ability to communicate effectively

Location:

can be based in Dreux, Les Ulis (France), Dublin (Ireland), Wrexham (UK)

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