Assoc Spec, Documentation
- Celgene Corporation
- Date de publication
Assoc Spec, Documentation
- 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
- 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.
- 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