Quality Assurance Manager/Clinical Packaging

m/f/d, Basel-Stadt

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.

Duration: 12 months/possible extension

Home office: 20%

Workload: 100%

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)

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