QC Scientist - Microbiology Pharma (80 - 100%)
* Full-time
Responsibilities
* Lead projects focused on the implementation of new analytical methods and new equipment into the microbiological laboratory (e.g. identification methods, utility testing).
* Plan and coordinate with internal (e.g. QA, customer service) and external stakeholders (e.g. supplier).
* 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 related to equipment qualification (URS, QP, DQ, IOQ) and method validation and transfer (protocol, reports).
* Train and mentor laboratory staff.
Supervision and project management
* Supervision of customer projects with focus on utility qualification testing, as well as related subcontracted analytical services within the Eurofins Group.
* Planning and organization of customer projects and related deliverables (e.g. review of technical documents, plans and validation reports).
* Mapping and configuration of projects in the LIMS system.
* Ensuring that the commissioned analytical work is carried out properly and on time, as well as co-responsibility for GMP-compliant execution.
* Approval of analysis results and reports.
* Supervision and scientific support of ongoing customer projects and participation in the acquisition of new projects.
* Processing laboratory deviations and root cause analyses (OOS).
* General process optimization and further development of the site.
Qualifications
* Completed studies in the field of 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 the field of microbiology and clean water analysis.
* Technical expertise on utility testing like TOC, conductivity, cleaning validation, gas testing) is a plus.
* 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.
#J-18808-Ljbffr