Quality Assurance Manager m/f/d, Basel-StadtThe IMP Quality Systems and Qualification/Validation team plays a central role in ensuring GMP compliance of facilities and systems used for the production of investigational medicinal products.
The team covers production facilities for the chemical synthesis of small molecules and nucleotides, solids formulation, sterile filling, packaging and analytics, as well as CSV systems. We are looking for a person who can handle the technical QA oversight and help maintain the highest quality standards.
Location: Basel
Workload: 60-80%
Contract duration: 1 year, with possible extension
Languages: German and English
Responsibilities: - QA oversight of qualification and validation activities for GMP-relevant plants and systems in drug substance and/or drug product manufacturing
- QA Oversight of CSV Systems
- Support the implementation of data integrity requirements.
- Review and approval of GMP documents (e.g. qualification plans, reports, change and deviation management, CAPAs, SOPs, risk analyses).
- Perform in-depth root cause analysis to solve complex problems.
- Driving optimization and improvement activities within IMP Quality
- Collaborate with stakeholders and contribute to the achievement of common goals
- Representing the area of responsibility during inspections by health authorities and internal audits.
- Supporting end-to-end cGMP activities and maintaining the right to operate
Requirements: - Fluent in German is mandatory
- Academic degree in engineering, chemistry, life science, pharmacy or comparable
- At least 5 years of professional experience in the pharmaceutical industry, including at least 2 years in the field of Quality Assurance
- Min. 3 years of experience in plant qualification/validation
- Understanding of current data integrity (DI) requirements
- Knowledge of global quality and GMP requirements
- Proven success in inspections by health authorities and internal GMP audits
- Strong team player with excellent communication and influence skills
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