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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Digital Quality Control initiatives, User Requirements development, and method validation within a GMP environment. Proficient in stakeholder management and collaboration between laboratories and IT, with strong language skills in German and English.
Highest-signal resume keywords
GMP KnowledgeUser Requirements DevelopmentProject Management ExperienceStakeholder Management SkillsFluency in German and English
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
User Requirements SpecificationMethod ValidationChange Request CreationAnalytical Method DevelopmentDigital ImplementationNeeds AnalysisCorrective Action ImplementationTechnical Solution DesignLaboratory Method DigitizationQuality Control Expertise
Soft Skills
Methodical ThinkingStrong Teamwork SkillsIndependent LearningAccountabilityCommitment to Quality
Tools & Technologies
NEXTLabVeeva VaultEVALLES Templates
Certifications & Qualifications
Laboratory Technician TrainingChemical Process Operator TrainingPharmaceutical Technician Training
Industry Keywords
GMP EnvironmentQuality AssuranceDeviationsCAPAsRegulatory InspectionsGMP/GDP KnowledgeCSV Knowledge
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Drives the Digital QC initiative in Basel/Kaiseraugst
- Creates User Requirements for analytical methods and implements them digitally in NEXTLab
- Supports the process from concept development and validation in eVAL through to support for Changes, Deviations, and CAPAs
- Develops User Requirement Specifications for NEXTLab recipes in collaboration with QC analysts
- Collects and structures relevant information for needs analysis
- Serves as the point of contact for laboratories and NEXTLab method developers at the Basel site
- Creates Change requests in Veeva Vault and coordinates with BPE and Quality Assurance
- Designs and presents technical solution proposals for digitizing laboratory methods
- Creates and optimizes method and LES templates
- Systematically and comprehensively documents development activities
- Validates method recipes and conducts user training
- Implements corrective actions related to Deviations, audits, and regulatory inspections
- Collaborates with NEXTLab 1st-level support to ensure smooth operations
Requirements
What you’ll need- Solid professional experience in a GMP environment, ideally complemented by QC expertise
- Training as a laboratory technician, chemical process operator, or pharmaceutical technician with several years of practical experience—or alternatively, a university degree in a natural science
- Programming or development experience is an advantage
- Ability to independently learn new systems and proactively expand knowledge
- GMP/GDP knowledge is essential
- CSV knowledge is an advantage
- Methodical thinking and strong stakeholder management skills in a global environment
- Project management experience and strong teamwork skills
- Interest in providing a central service at the interface between laboratories and IT
- Independent and accountable personality with a strong commitment to quality
- Fluency in German and English is essential, both written and spoken, at least B2 level
- French language skills are an advantage
- Current CV and relevant certificates
Benefits
Comp & perks- Equal Opportunity Employer
- Personal and professional development in an inclusive culture
- Opportunity to contribute to healthcare solutions with global impact