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Job Post Details

Quality Engineering Specialist - job post

EPM Scientific
3.3 out of 5
Suisse

Lieu

Suisse

Description du poste

EPM Scientific have partnered with a Global Leader in Biotechnology who are seeking a Quality Engineering Specialist on a contract basis to join their expanding dynamic team.

Main Responsibilities:

  • Oversight of quality and regulatory aspects related to the designated CAPEX project.
  • Ensuring compliance with Commissioning & Qualification (C&Q) requirements for GMP systems associated with the aseptic fill-finish facility (including equipment, utilities, and facilities) throughout the project lifecycle, from design engineering to initial C&Q and handover phases.
  • Reviewing and approving C&Q documents for GMP systems, as well as related changes and deviations.
  • Assisting in audits and regulatory inspections (e.g., Swissmedic, FDA).
  • Providing leadership and guidance to project team members regarding C&Q strategy and addressing related issues.
  • Ensuring that decisions are well-supported by both global and local Quality, as well as Regulatory departments.
  • Promptly escalating issues and taking the lead in resolving them.

Key Requirements:

  • Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
  • Demonstrated extensive experience within the GMP regulated pharmaceutical sector, ideally in a Quality Unit capacity.
  • Proficiency in English is required, with fluency in German considered advantageous.

Please apply using the link provided or contact me via / +41 44 542 12 77

  • Please note, only those with the right to work in Switzerland can apply

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