Quality Assurance Manager/Clinical Packaging
As an employee of the Quality Organisation, you will ensure compliance with and continuous improvement of GMP compliance of the production companies at the Basel site. The task of the Synthetic Molecules Quality Group includes in particular the quality oversight of the Synthetic Molecules Drug Substance and Drug Product operations, as well as the associated QC control.
Responsibilities:
* Review and release of documents such as: analytical methods, method validations, specifications, risk assessments, deviation reports and investigations, change control records, stability reports.
* Preparation of product-related quality agreements.
* Support of the supervised departments with GMP-relevant issues.
* Carrying out self-inspections.
Requirements:
* Degree in natural sciences.
* Fluent written and spoken German and English skills.
* At least 5 years of experience in the pharmaceutical industry.
* Ideally professional experience in the field of pharmaceutical development (synthetic molecules, quality control or quality assurance).
* Knowledge of cGMP and quality requirements, ideally for clinical development phases.
* Good IT skills (MS Office) - especially the handling of SAP, as well as other quality management systems (e.g. Veeva).
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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