Expert in Microbiology and Monitoring (QC) | Biologe (m/w/d)
Daiichi Sankyo Europe GmbH
Job Summary
Join Daiichi Sankyo, a global pharmaceutical company dedicated to improving lives through innovative medicines, as an Expert in Microbiology and Monitoring (QC) at our Pfaffenhofen site. In this role, you will provide technical expertise for microbiological analyses, manage projects in monitoring and microbiology, and serve as a key contact for Quality Assurance, production, and quality management. You will actively participate in audits and inspections, oversee laboratory workflows, and evaluate hygiene monitoring results. The position requires a scientific degree or equivalent education, several years of professional experience in microbiological quality control or aseptic manufacturing, and familiarity with GMP-relevant documentation and regulatory requirements. This is an excellent opportunity to contribute to a company focused on oncology, cardiovascular diseases, rare diseases, and immunology, while fostering personal growth and work-life balance.
Required Skills
Education
Completed scientific degree or comparable training
Experience
- Several years of professional experience in microbiological quality control
- Alternatively, several years of professional experience in aseptic manufacturing and/or hygiene monitoring, preferably in the pharmaceutical sector
- Experience in the testing for endotoxins is desirable
- Profound experience in the creation and review of GMP-relevant documents with a focus on microbiological quality control and hygiene monitoring
- Familiarity with (authority) inspections and their requirements
Languages
Additional
- Familiarity with regulatory requirements, particularly EC-GMP Guideline Annex 1, FDA Aseptic Guide, ISO 14644 is desirable. SAP knowledge is advantageous.
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