Quality Assurance Manager Manufacturing Unit Monoclonal Antibodies m/f/d, Basel-StadtAs Quality Assurance Manager Direct Materials, you will make a decisive contribution to quality oversight via the qualification and release of raw materials. In this role, you will be responsible for maintaining and continuously optimizing the quality system, always taking into account current legal and internal requirements. The network is expanded through changing areas of application and actively contributes to the harmonization of processes.
The perfect candidate has a university degree in a scientific or engineering field (e.g. biology, chemistry, pharmacy, biotechnology) and at least 1-3 years of professional experience in the field of quality assurance or GMP compliance, or at least 3 years in a GMP regulated work environment.
Contract start date: As soon as possible
Contract end date: September 2026
Location: Basel
Responsibilities: - Central contact person for purchasing, QC and production companies in all quality issues, for raw material approval and qualification.
- Ensuring quality oversight and GMP compliance for the raw materials and projects served.
- Review, assess and approve specifications, both on paper and in SAP/SLIMs
- Responsibility for the release of direct materials
- Process, assess, and approve deviations, corrective actions (CAPAs), and technical change requests.
- Self-inspections and support internal audits and authority inspections.
- Active contribution of ideas for the continuous improvement of processes and support in the implementation of them.
Requirements: - Completed university degree in a scientific or engineering field (e.g. biology, chemistry, pharmacy, biotechnology)
- Experienced in dealing with common IT systems in the pharmaceutical industry
- Min. 1 year of professional experience in the field of Quality Assurance or GMP Compliance, or 3 years in a GMP regulated working environment
- Strong team player with excellent communication skills
- High quality awareness and an independent, result-oriented and assertive way of working
- Fluent communication in German and English (spoken and written)
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