Lead and continuously improve the GMP self-inspection program, including annual planning and executionCoach SMEs and audit teams to ensure strong inspection and self-inspection readinessPerform gap assessments on global procedures and drive alignment across site functionsCoordinate cross-functional activities and ensure effective communication with all departmentsSupport internal, external, and mock audit preparation, including document review and QA inputAct as backroom/ACC or scribe team member during audits and inspectionsServe as Data Integrity Champion and ensure consistent DI implementation across the sitePrepare and present compliance topics to the Quality Council and site leadershipSupport continuous improvement initiatives and coordinate operational activities within the compliance teamAct as back-up for the Quality Compliance & Systems Expert when required University degree in biochemistry, chemistry, engineering, or another relevant scientific/technical disciplineSolid experience in biotechnology and/or pharmaceutical industryStrong knowledge of GMP requirements and Quality SystemsUnderstanding of manufacturing, QC laboratory, and warehouse processes for biological productsSolid knowledge of Good Documentation Practices (GDDP) and Data Integrity principlesExperience supporting audits and regulatory inspectionsSkilled in writing, reviewing, and updating SOPs and technical documentationFamiliarity with risk management tools (FMEA, RCA, etc.)Proficiency in French and English (minimum B2)Experience with eQMS tools (e.g., Veeva Vault, TrackWise), Microsoft Office, SharePoint, and Power BI A very renowned companyContinuous support during the assignmentIndividual all-round care: Support throughout the entire application phase Ihr Kontakt Referenznummer 864224/1 Kontakt aufnehmen Telefon:+41 44 225 50 00 E-Mail: positionen@hays.ch Anstellungsart Freiberuflich für ein Projekt
Proficiency in French and English (minimum B2) Experience with eQMS tools (e.g., Veeva Vault, TrackWise), Microsoft Office, SharePoint, and Power BI A very renowned company Continuous support during the assignment Individual all-round care: Support throughout the entire application phase Ihr Kontakt Referenznummer 864224/1 Kontakt aufnehmen Telefon:+41 44 225 50 00 E-Mail: positionen@hays.ch Anstellungsart Freiberuflich für ein Projekt