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
Lead and continuously improve the GMP self-inspection program, including annual planning and execution Coach SMEs and audit teams to ensure strong inspection and self-inspection readiness Perform gap assessments on global procedures and drive alignment across site functions Coordinate cross-functional activities and ensure effective communication with all departments Support internal, external, and mock audit preparation, including document review and QA input Act as backroom/ACC or scribe team member during audits and inspections Serve as Data Integrity Champion and ensure consistent DI implementation across the site Prepare and present compliance topics to the Quality Council and site leadership Support continuous improvement initiatives and coordinate operational activities within the compliance team Act as back-up for the Quality Compliance & Systems Expert when required University degree in biochemistry, chemistry, engineering, or another relevant scientific/technical discipline Solid experience in biotechnology and/or pharmaceutical industry Strong knowledge of GMP requirements and Quality Systems Understanding of manufacturing, QC laboratory, and warehouse processes for biological products Solid knowledge of Good Documentation Practices (GDDP) and Data Integrity principles Experience supporting audits and regulatory inspections Skilled in writing, reviewing, and updating SOPs and technical documentation Familiarity with risk management tools (FMEA, RCA, etc.)
HPA - Hamburg Port Authority AöR sucht in eine/n Werkstudent*in in der Technical Division (ID-Nummer: 13623533)
HPA - Hamburg Port Authority AöR sucht in eine/n Data Governance Manager*in in der Technical Division (ID-Nummer: 13745001)
Lust auf was neues? Dann starte mit uns durch! Wir suchen aktuell: Technical Consultant / Techniker im Facility Management (m/w/d) in Bad Oeynhausen Technical Consultant / Techniker im Facility Management (m/w/d) in 32549 Bad Oeynhausen Die ambrosia ist eine mittelständische Unternehmung für Facility Management Dienstleistungen und Beratung.
Ruhr: Strategic, analytical mindset with strong data quality focus Independent, ownership driven working style Clear and structured documentation skills Mentoring and knowledge sharing mindset At least six years' experience in implementation projects, of which at least two years must have been spent in thematically comparable IT projects, Special knowledge in several technical areas, PM: At least two years' experience in IT project management with full management responsibility for the project staff, Management of Cat.