Quality & Compliance Specialist

3/2026 – 8/2026

Senior validation consulting for retrospective validation activities within a GMP-regulated pharmaceutical manufacturing environment. Independently planned, coordinated and executed Retrospective Validation (RV) activities for manufacturing processes in GMP Grade D cleanroom environments. Performed structured research and evaluation of historical validation data, batch records and manufacturing documentation using eVAL Roche, Veeva Vault, SAP and archive systems. Prepared retrospective validation plans, protocols and reports in accordance with Roche validation standards and internal quality procedures. Coordinated validation activities with MSAT, Manufacturing Operations, Engineering Science & Technology (ES&T), Quality Assurance (QA) and Quality Control (QC). Took technical responsibility for validation reports and lifecycle documentation, including review and approval activities. Managed deviations, exceptions, change controls and planned events and supported Root Cause Analyses (RCA), manufacturing investigations and traceability assessments. Ensured complete, compliant and audit-ready GMP documentation throughout the validation lifecycle.

Consultant

12/2025 – offen

Support of an FDA remediation program focusing on microbiological control and aseptic processing compliance. Development and update of the Contamination Control Strategy (CCS) and definition of an environmental monitoring concept in alignment with FDA and GMP expectations. Performed structured assessments of Grade A filling lines equipped with RABS and isolators, with particular focus on glove and glove extender configurations during VHP/H2O2 decontamination. Reviewed internal SOPs, validation requirements and contamination control measures related to glove positioning and decontamination effectiveness. Prepared an assessment report to support the company's response to FDA observations, including risk evaluation and justification of the existing contamination control strategy. Defined and derived procedural, organizational, technical and validation-related risk mitigation measures as part of the remediation action plan to establish sustainable regulatory compliance.

Consultant

7/2025 – 11/2026

Support for hygiene qualification documentation for a fully automated Abbott cartridge assembly line in accordance with GAMP, GMP, SIM Automation standards and customer requirements. Reviewed customer requirements and technical specifications and prepared qualification documentation for DQ, IQ, OQ and PQ. Defined operator roles and access authorizations as part of the qualification strategy and incorporated GxP-compliant access control requirements into system descriptions and operator concepts. Coordinated qualification scope and documentation content with the customer and supported the completion and review of qualification lists and records to ensure regulatory and project-specific compliance. The system included Taktomat-based workpiece transport, pneumatic and electric handling units, integrated vision inspection and PLC/HMI control architecture.

Consultant