06.02.2026 aktualisiert
100 % verfügbar
Senior Consultant for Validation and Digitalisation in Pharmaceutical Environments
Würzburg, Deutschland
Deutschland +2
Master of Science (Biology)info: Deutschland, Österreich, Schweiz
Über mich
Extensive experience in IQ/OQ/PQ execution, commissioning, and qualification of lab and process equipment, including GMP documentation. Strong background in assay-based methods such as Endotoxin, ELISA, flow cytometry, and PCR, with hands-on support in tech transfers and equipment implementation.
Skills
AsepsisAtlassian JiraAuditsBioreaktorenISO 9000Good Manufacturing PracticesSoftwaredokumentationComplianceDocumentumStandardverfahrenIso 13485ProjektmanagementMicrosoft ProjectQualitätsmanagementRisikoanalyse
GMP Compliance
Comprehensive experience working in GMP-regulated environments for pharmaceutical, medical device, and CRO clients.
Validation and Quality Management
Expertise as a CSV trainer and team lead, responsible for planning and executing validation activities.
Regulatory Affairs
Experience in preparing and maintaining regulatory documentation and supporting internal and external audits.
Project Management
Leadership of cross-functional teams with responsibility for ensuring project execution in compliance with regulatory requirements.
Technical Documentation
Preparation and review of risk assessments, Site Acceptance Tests (SAT), SOPs, and specification documents.
Quality Systems
Implementation and maintenance of quality management systems in accordance with ISO 13485 and ISO 9001.
IT Skills
Proficient in MS Office, Veeva Vault, MS Project, Techshare, Documentum, SAP, and Jira.
Erfahrung
Berufserfahrung5 - 10 Jahre
Freelancer seit2019
Sprachen
DeutschMutterspracheEnglischverhandlungssicherFranzösischGrundkenntnissePolnischgut
Projekthistorie
Extensive hands-on experience in IQ/OQ/PQ execution, commissioning and qualification of laboratory and process equipment, and preparation of robust GMP documentation.
Strong background in laboratory methods and assay-based testing, including Endotoxin assays, ELISA, flow cytometry, and PCR, combined with practical project support for tech transfers, equipment implementation, and cross-functional coordination in regulated environments.
Provided support to a major pharmaceutical company in adapting a final filling line for a newly introduced liquid Supported a vaccine manufacturer in the adaptation and qualification of an aseptic filling line for a newly introduced liquid drug product. The assignment focused on GMP-compliant equipment qualification, structured qualification documentation, and hands-on execution in a production and laboratory environment.
Managed product development and validation activities for a medical device designed to monitor anesthesia depth. The role operated at the interface between development, quality, regulatory requirements, and customer application.