Associate Specialist QA Documentation

STA Pharmaceutical Switzerland SA

Couvet
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STA Pharmaceutical Co., Ltd. (STA), a WuXi AppTec company, is a global leading small molecule pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations in China, the United States and Europe. As a premier Contract Development and Manufacturing Organization (CDMO), STA offers our worldwide partners efficient, flexible and high-quality solutions for small molecule Active Pharmaceutical Ingredients (APIs) and finished dosage forms. 

We are looking for our site in Couvet - in the Canton of Neuchatel in Switzerland for an

Associate Specialist QA Documentation

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.

 

Contact

  • STA Pharmaceutical Switzerland SA

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