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