Location: Basel
Contract duration: 12 months
Responsibilities
* Review of Drug Product Batch Records, in cooperation with the relevant departments.
* Implementation of the IMP Drug Product release.
* Review and release of documents such as: specifications, risk assessments, deviation reports and change control records.
* Review and approval of cleaning protocols and reports.
* Support of the supervised departments with GMP-relevant issues.
* Conducting self-inspections.
Requirements
* Completed scientific studies, at least at Master's level.
* Fluent written and spoken German and English skills
* At least 10 years of professional experience in the pharmaceutical industry, of which at least 5 years in quality assurance.
* Knowledge of cGMP and quality requirements for clinical development phases.
* Proven success in inspections by health authorities and internal GMP audits.
* Good IT skills (MS Office) - especially the handling of SAP, as well as other quality management systems (e.g. Veeva Vault).
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