30.09.2025 aktualisiert
verifiziert
Premiumkunde
40 % verfügbarSenior QA/CSV Consultant
Frankfurt, Deutschland
Weltweit
Genetics (Molecular Biology) and Electronics (Technical Informatics)Skills
21 CfrAuditsBiotechnologieKorrektur- und VorbeugemaßnahmeChange ControlKollaborationsplattformComplianceDatenvalidierungDatenintegritätProjektmanagementQualitätsmanagementMicrosoft SharepointVerifizierung und ValidierungStakeholder ManagementValidierungstestsIq/oq/pqBeurteilungen DurchführenValidierungsprotokolleAbweichungsmanagementSystem-ImplementierungenGerätequalifizierungMicrosoft TeamsVirtuelle TeamsGmp-gerechte DokumentationProjektlieferungValidierung von ErgebnissenGXP
Professional Summary
Experienced Senior QA and CSV Consultant with over a decade of expertise delivering GxP-compliant validation solutions for pharmaceutical, biotech, and medical device companies. Specialized in remote-first project delivery, managing cross-site teams to ensure inspection readiness and regulatory compliance (GAMP 5, EU Annex 11, 21 CFR Part 11). Proven ability to lead complex CSV strategies and data integrity remediations virtually, partnering effectively with international stakeholders to achieve audit-ready outcomes.
Core Competencies
Experienced Senior QA and CSV Consultant with over a decade of expertise delivering GxP-compliant validation solutions for pharmaceutical, biotech, and medical device companies. Specialized in remote-first project delivery, managing cross-site teams to ensure inspection readiness and regulatory compliance (GAMP 5, EU Annex 11, 21 CFR Part 11). Proven ability to lead complex CSV strategies and data integrity remediations virtually, partnering effectively with international stakeholders to achieve audit-ready outcomes.
Core Competencies
- Remote CSV Strategy Development & Execution
- GAMP 5, EU Annex 11, 21 CFR Part 11 Compliance
- Data Integrity Remediation (Remote Assessments)
- Audit and Inspection Readiness (FDA, ANVISA, Swissmedic, AGES, Chinese FDA)
- Cross-Functional Virtual Team Leadership
- Change Control, CAPA, Deviation Management
- Validation Planning and Documentation (IQ/OQ/PQ)
- Project Management for Computerized System Implementations
- Remote Collaboration Tools (MS Teams, SharePoint, Veeva Vault, Kneat)
Sprachen
DeutschMutterspracheEnglischverhandlungssicherSpanischgut
Projekthistorie
- Delivered remote qualification support for analytical instruments.
- Risk assessments, URS development, and qualification protocol drafting.
- Conducted 21 CFR Part 11 gap analysis and planned remediation activities.
- Supported Audit Trail setup via 3rd-party software (SMART Audit Trail).
- Defined and implemented quality systems and CSV strategies for international clients, delivering projects primarily remotely. Ensured cGMP, EU GMP, ISO 9001, ISO 13485, 21 CFR Part 4/11, EU GMP Annex 11, and GAMP 5 compliance.
- Led remote project management for CSV of ERP, DMS, BMS, and production systems.
- Delivered audit and inspection readiness support for FDA, Swissmedic, and other agencies.
- Partnered with QA and IT functions to deploy electronic systems and compliance solutions remotely.
- Implemented QA Activities Planning Tool (SharePoint-based).
- Prepared for Swissmedic and FDA pre-approval inspections.
- Conducted 6S-audits and led Gemba walks.
- Oversaw activities for equipment qualification and CSV remotely and on-site.
exali Berufshaftpflicht-Siegel
Das original exali Berufshaftpflicht-Siegel bestätigt dem Auftraggeber, dass die betreffende Person oder Firma eine aktuell gültige branchenspezifische Berufs- bzw. Betriebshaftpflichtversicherung abgeschlossen hat.
Versichert bis: 01.01.2026