Job Overview
The Quality Assurance Manager/Clinical Packaging role is responsible for ensuring compliance with and continuous improvement of GMP standards at the Basel site. This includes quality oversight of Synthetic Molecules Drug Substance and Drug Product operations, as well as associated QC control.
Key Responsibilities
* Review and approval of critical documents such as analytical methods, method validations, specifications, risk assessments, deviation reports, investigations, change control records, and stability reports.
* Development of product-related quality agreements.
* Support to supervised departments on GMP-related matters.
* Conducting self-inspections and audits.
Requirements
* Bachelor's degree in a natural science field.
* Fluent German and English language skills.
* At least 5 years of experience in the pharmaceutical industry.
* Prior experience in pharmaceutical development (synthetic molecules, quality control or quality assurance) is highly desirable.
* Knowledge of cGMP and quality requirements, particularly for clinical development phases.
* Strong IT skills, including MS Office and 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