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CMC Project Coordinator/GMP

m/w/d, Basel-Stadt

This position is located in Preclinical Chemistry, Manufacturing, and Controls (pCMC), a department within the Small Molecule Research organization.

Start date: Immediately, latest 1st June

Duration: 1 year

Responsibilities:

Management of local and global compliance processes like GMP training, archiving, quality risk management, handling of multisite and local impact assessments
Being an expert and first level support for relevant quality systems (e.g. Cornerstone, Veeva OneQMS, QualityDocs, QRM,)
Managing changes and deviations, as well as corrective and preventive actions in consultation with QA
Provide expert support to monitor, update, and adapt the GMP-relevant document landscape within pCMC
Participating in the preparation and coordination of internal and health authority audits, as well as supporting the timely implementation of inspection findings
Collaborating with team members in a role based working environment, as well as building and growing relationships with customers and partners across functional boundaries

Requirements:

Bachelor or equivalent and/or higher degree in chemistry, biology or pharmaceutical sciences
Operational experience in a GMP environment within the pharmaceutical industry
MS office / standard Google applications
Fluent in German and English