Quality System Specialist in Bern

Audrey Bisch, Basel Professionals Health Care & Life Sciences
jetzt bewerben

job details

Life Sciences
Audrey Bisch, Basel Professionals Health Care & Life Sciences
058 201 55 50


For one of our client, a big pharmaceutical company in Bern, we are currently looking for a Quality System Specialist

Position overview

The Quality Systems Specialist position aim to support the maintenance of the Quality Issue Management Process (QIMP) by ensuring its continuous improvement, as well as, providing training on Root Cause Analysis and on the design of compliant Corrective/Preventive Action(s) and Effectiveness Check Plans.

In addition, the position also aims the participation as a team member in a site project by supporting the Document Owners in defining and writing their processes in compliance with the local Quality Management System Framework and Good Documentation Practices.


Tasks & Responsibilities:

  • Provide system and process training for new users on the QIMP Process: issue description (including compliance writing requirements), issue impact assessment, root cause analysis, CA/PA and Effectiveness Checks plans definition
  • Provide continuous support for the users in using the system and coaching them in the QIMP process adherence 
  • Support the Process Owner on the users management, and in the organization of local implemented Boards for managing ETS records completion according to the defined KPIs
  • Review and approves routine incoming process documents assuring compliance with the current Quality Management Systems requirements as defined in the local Quality Manual
  • Mentor Document Owners in defining their processes, suggesting processes improvements/KPIs and writing a compliant documentation assuring Good Documentation Practices
  • Contribute to the creation and maintenance of documentation and records for area of responsibility - may include Standard Operating Procedures (SOPs), Work Instructions (WIs), and other quality documentation.

Qualifications & Experience

  • University degree in Natural Science, Medicine or Pharmacy
  • Profound knowledge of cGMP regulations and Quality Systems processes especially Nonconformances, Change Controls, Documentation Management and Training
  • Profound experience in facilitating and performing Root Cause Analysis
  • 3 – 5 years working experience in a GMP environment, preferably in Quality
  • English and German (fluently)
  • Strong ability in dealing with IT systems such as TrackWise
  • Strong written, oral, and presentation skills.
  • Ability to work in a matrix environment where priorities change rapidly, and tight deadlines exist.
This is for a one year contract starting in August 2021. It can lead in time to a permanent position.