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Assoc Spec, Documentation

Celgene Corporation
Date de publication


Assoc Spec, Documentation


Documentation management:

  • Ensure Quality Documentation complies with established Celgene electronic Documentation System standards & document management policies
  • Provide timely and efficient support to the Documentation and Training Systems users in handling document workflows and document change request
  • Monitor progress of documents in workflows, ensure timely follow up and completion
  • Proactively manage the Quality documents Periodic Review Process
  • Coordinate with the International Affiliates, activities and projects related to the management of their local Quality System documents

Archive management:

  • Ensure Documentation & Records are archived and retained in compliance with Celgene policies
  • Provide support and guidance to document owners /departments in regards to documents and records archiving process.
  • Responsible for physical & electronic archiving process using FileTrail, as well as archives periodic reconciliation.
Training management :
  • Responsible for the creation and assignment of GMP/GDP training in Celgene electronic Learning Management system (ComplianceWire)
  • Create, update and assign Personnel Training profiles and curriculum in accordance with Training management request.
  • Define and execute improvement projects related to the LMS system such as curriculum review, user group or user profile review.

In addition

  • Act as Administrator and Super User of the electronic Documentation Management System & LMS ComplianceWire
  • Train users on the Documentation, Training and Archiving process/ systems
  • Assist with the development / writing of SOPs in regards to document management, archiving
  • System and LMS system
  • Compile applicable trending metrics for management review purposes
  • Provide support in the preparation of the required documentation during internal audits and/or external inspections
  • May manage temporary resources providing administrative support, like for instance Associate Coordinator Documentation function, by assigning to them


  • Economic or administrative degree or equivalent training/education.
  • A minimum of 5 years of working experience in a pharmaceutical company or other related industry.
  • Experience in handing of GMP/GDP/Quality Documentation & Training
  • Fluent in French and English.
  • Knowledge of the most common MS Office software
  • Good organization skills
  • Good communication and ability to work in multicultural and evolving environment.
  • Proactive, solution & continuous improvement oriented