GMP Compliance Expert

Location: Basel

Contract duration: 1 year

As a GMP Compliance Expert in the field of Enable Compliance, you are in the field of Technology. You are responsible for the realization and Maintenance of the biotechnological, chemical and galenic production facilities of the Pharmaceuticals Division at plants. In addition, the area Technology for the GMP-compliant operation of infrastructure facilities and areas supply systems (water and gases).

Tasks & Responsibilities:

• Coordination / implementation and cooperation in the deviation, change, risk and event management (Deviation, Quality Incident).
• Supporting internal customers as a recognized consultant in all technical GMP
• Issues, e.g. documentation of PE changes / events.
• Process Management System – creation, review and update of documents.
• Examination of the latest developments in cGMP, continuous improvement of the processes as well as the systems used.

Requirements:

• Completed technical training or studies in the technical field as well as at least 3 years of practical experience in the field of compliance / quality assurance of pharmaceutical, chemical or biotechnological plants.
• At least 3 years of practical experience in the implementation of technical GMP requirements of the regulatory authorities (Swissmedic, FDA, EMA, etc.) in projects or in galenic / chemical production.
• Good IT skills (e.g. Google Suite, Microsoft) and affinity to familiarize yourself with new programs.
• Very good knowledge of German, both written and spoken.