Beschreibung

As a QC Scientist, you will lead innovative projects in a GMP-regulated lab, ensuring compliance while implementing new analytical methods. This role involves coordinating with stakeholders, training staff, and optimizing processes to support customer projects.

Anforderungen

• •Completed studies in life sciences (pharmacy, biochemistry, biology, ideally microbiology)
• •At least 3 years of relevant professional experience in a regulated environment (ISO 17025, GLP, ideally GMP)
• •Experience in pharmaceutical quality control in microbiology and clean water analysis
• •Technical expertise on utility testing like TOC, conductivity, cleaning validation, gas testing
• •Strong customer and service orientation
• •Solid understanding of IT and Office applications, ideally experience with LIMS systems
• •Affinity for digitalization and computer system validation
• •Ideally experience in project management
• •Business driven mindset
• •Team player, responsible, reliable and flexible
• •Excellent German and good English skills
• •French is an advantage

Aufgaben

• •Lead projects to implement new analytical methods and equipment in the microbiological laboratory
• •Plan and coordinate with internal and external stakeholders
• •Ensure compliance with GMP, regulatory guidelines, and internal quality standards
• •Manage project timelines, resources, and deliverables
• •Provide technical expertise on analytical methods
• •Prepare and review documents for equipment qualification and method validation
• •Train and mentor laboratory staff
• •Supervise customer projects focused on utility qualification testing
• •Plan and organize customer projects and related deliverables
• •Map and configure projects in the LIMS system
• •Ensure proper and timely execution of commissioned analytical work
• •Approve analysis results and reports
• •Support ongoing customer projects and assist in acquiring new projects
• •Process laboratory deviations and conduct root cause analyses
• •Optimize general processes and further develop the site

Tools & Technologien