Ref: JN-082021-191481

Publié le 04 August 2021
Location
Geneva
Catégorie
Sciences de la vie

We are recruiting, on behalf of our client, a CSV Associate with experience in the pharmaceutical industry.

At this role, you will be responsible for the CSV activities on the laboratory and manufacturing equipments.

  • Define the validation strategy and author key validation deliverables for multiple systems in areas such as: laboratory instruments software, electronic logbooks, GMP data collection middleware, etc.
  • Directly responsible for completing system impact/risk assessments and data integrity assessments, for authoring validation plans, test plans, requirements traceability matrices, validation summary reports, etc.
  • Leveraging the existing Validation Master Plan, validation SOPs and Data Integrity assessments defined at enterprise level.
  • Define the validation approach for change controls based on scope and risk and help maintain validated state for regulated systems.
  • Contribute and collaborate on CSV activities for enterprise-level, multi-site lab and manufacturing systems.
  • Work collaboratively to ensure the development of CSV best practices to support the timely delivery of validated computer systems for internal clients.
  • Fluency in English and French is mandatory.
  • Communication with US counterparts, particularly the CSV team.
  • Lead presentations to review the CSV activity in Geneva or to help improve CSV practices.

  • BS or relevant degree with at least 4 years of CSV experience in a GxP environment in the pharmaceutical industry.
  • Experience defining the validation approach for computer systems.
  • Excellent knowledge of Part 11 and Annex 11 regulatory requirements as well as Data Integrity expectations. Experience ensuring these requirements are specified, fulfilled, and tested for regulated computer systems.
  • Experience working with laboratory instruments and manufacturing systems and validating the associated software is desired.
  • Ability to prioritize, good written and verbal communication skills.

#boost