GMP Compliance Expert

Contract Duration: 12 months

Responsibilities:

• Ensuring that the official and regulatory requirements are met in operational operations
• Responsible for ensuring operational compliance for site media systems (process water and gases) in the GMP regulated environment Initiating and processing deviation, change, risk and change processes.
• Support of the Circle and Sub circle as a recognized consultant in all technical GMP issues, e.g. documentation of deviations and changes.
• Creation, review and updating of documents.
• Testing of the latest developments in cGMP, continuous improvement of processes and systems used.
• Prepare reports (trending reports, etc.), assess key figures for operational compliance and initiate measures where necessary. Carry out logbook checks.

Requirements:

• Completed vocational training or a bachelor's/master's degree, ideally in the field of pharmaceutical manufacturing or a related field.
• Excellent German
• At least 3 years of practical experience in the field of compliance or quality assurance of pharmaceutical and/or technical facilities in a GMP regulated environment.
• Practical experience in the implementation of technical GMP requirements of the regulatory authorities (FDA, EMA, etc.) in investment projects or in galenic / chemical production.