Durée indéterminée

On behalf of our client, a growing company based in Neuchâtel, we are currently looking for a

Associate Specialist QA Documentation

Vos tâches

Job Summary:

 

This position is responsible to support the Quality Documentation management system (DMS) and GMP/GDP Learning Management system (LMS), its maintenance and continuous improvement. In addition, the position holder supports the GMP/GDP Training management system, including the maintenance of the LMS.

 

Essential Job Functions:

 

Documentation management:

 

  • Ensure Quality Documentation complies with established electronic Documentation System standards & document management policies (act as document reviewer / approver).
  • 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.

 

Archive management:

  • Ensure Documentation and Records are archived and retained in compliance with applicable policies (storage, retrieval for consultation, destruction).
  • Provide support and guidance to document owners /departments for documents and records archiving process.
  • Responsible for physical and electronic archiving process as well as archives periodic reconciliation and coordinate records destruction.

 

Training management:

  • Responsible for the creation and assignment of GMP/GDP training in electronic Learning Management system.
  • Create, update and assign Personnel Training profiles and curriculum in accordance with LMS request.
  • Manage IT GMP LMS request enabling user to get access to IT GMP systems (curriculum assignment and training completion verification).

 

In addition:

  • New employee GMP on boarding process coordination and monitoring.
  • Act as Administrator and Super User of the electronic Documentation Management System and Learning Management System.
  • Train users on the Documentation, Training and Archiving process/ systems.
  • Provide support in the preparation of the required documentation during internal audits and/or external inspections.

Votre profil

Job Requirements:

 

Experience / Education  

 

  • Economic or administrative degree or equivalent training/education.
  • A minimum of 2-3 years of working experience in a pharmaceutical company or other related industry.
  • Experience in handing of GMP/GDP/Quality Documentation & Training appreciated.

 

Knowledge / Skills / Abilities:

 

  • Fluent in French, English (level B2).
  • Knowledge of the most common MS Office software.
  • Good organization skills, attention to details.
  • Proactive, solution & continuous improvement oriented.
  • Good communication and ability to work in multicultural and evolving environment.
  • Excellent team spirit.

 

Langues

  • Fluent in French, English (level B2).

Date d'entrée

À convenir


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