Ensure GMP-compliant introduction and release of manufacturing materials, including specifications, sampling plans, and documentation
Review analytical data in LIMS, including job authorization, result certification, and ensuring data integrity
Independently review and certify raw data, including internal and external Certificates of Analysis (CoA)
Manage deviations, Out of Specification (OOS) results, and change controls within the area of responsibility
Maintain audit and inspection readiness, including participation in customer and authority audits
Collaborate with QA and Supply Chain to resolve quality issues related to material batch release
Support creation of Material Qualification Forms and technical specifications in collaboration with process owners
Participate in Gemba Walks and mock audits to drive continuous improvement
Contribute to PPI projects and other QC processes as needed
Act as a subject matter expert, leading or supporting resolution of technical issues
Profile
Bachelor-s or Master-s degree in Life Sciences (e.g., chemistry, biochemistry, biology); alternatively, a laboratory apprenticeship with relevant industry experience may be accepted
Solid experience in GMP-regulated industries, ideally within global corporate environments
Hands-on experience in pharmaceutical Quality Control and/or Quality Assurance
Proven experience managing deviations, change controls, and CAPA processes
Strong collaboration skills with cross-functional teams to drive project success
Fluency in English is required; German proficiency is a strong asset
Experience with ERP systems, especially SAP, is advantageous
In-depth understanding of GMP regulations and standards to ensure compliance
Excellent technical writing skills for accurate documentation and reporting
Ability to work independently and act as a subject matter expert in assigned areas