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
