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Associate Specialist, QA Documentation

Req #: 1800233
Location: Boudry, Neuchatel CH
Job Category: Quality
Work Location: Route de Perreux 1 BOUDRY 2017
Organization: Celgene International SaRL
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:Switzerland- Boudry

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Skills/Knowledge Required

  • Economic or administrative degree or equivalent training/education.
  • A minimum of 3 years of working experience in a pharmaceutical company or other related industry.
  • Experience in handling GMP/GDP/Quality Documentation & Training, good understanding of their applicable requirements
  • Ability to focus attention to details, sense of commitment, rigor
  • Good organization skills- ability to coordinate and prioritize activities
  • Good communication and ability to work effectively in multicultural and evolving environment.
  • Proactive, solution & continuous improvement oriented
  • Knowledge of the most common MS Office software
  • Fluent in French and English

Duties and Responsibilities

The Associate Specialist QA Documentation has the following duties & responsibilities in regards to:

Documentation management:

  • Ensure Quality Documentation complies with established Celgene electronic Documentation System standards & document management policies
  • Provide timely and efficient support to systems users in handling document workflows and managing document change requests
  • Monitor progress of documents through the electronic workflows
  • Proactively manage the Periodic Review Process of quality documents
  • Assist with the development / writing of SOPs in regards to documentation and training management systems

Archive management:

  • Ensure documentation/records are archived and retained in compliance with Celgene policies
  • Provide guidance to document owners /departments in regards to data retention & records archiving process
  • Manage physical & electronic archiving process using FileTrail, perform archive periodic reconciliation and initiate the records destruction process as per applicable standard.

Training management:

  • Responsible for the creation and assignment of GMP/GDP training in Celgene electronic Learning Management system (ComplianceWire)
  • Create, update personnel training profiles and assign curriculum in accordance with training management requests
  • Coordinate periodic curriculum and user groups review
  • Train users on the Documentation, Training and Archiving process and associated IT systems in Internal Manufacturing areas and Affiliates (if applicable)

Related activities

  • Act as Administrator and Super-User of the electronic Documentation Management System  (Celdox) & LMS (ComplianceWire)
  • Provide support in the preparation of the required documentation during internal audits and/or external inspections

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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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