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Miscellaneous
ETL Datawarehouse
Lead analytical method validation, transfer, and lifecycle management across multiple sites (SEC-HPLC, ELISA, CGE, BET, UV, etc.). Manage change control processes, ensuring stakeholder alignment and timely approval. Drive regulatory compliance with global pharmacopoeias (EP, USP, JP, ChP). Coordinate analytical activities and stability studies to support manufacturing process changes. Conduct risk assessments for excipients, raw materials, and reagents. Serve as primary liaison with Regulatory Affairs for analytical dossiers and CoA approvals. Author validation protocols and reports, ensuring audit readiness and data integrity compliance. Mentor junior consultants and provide technical support to clients.
Planned and managed analytical method validation projects, ensuring compliance with USP/EP. Coordinated stakeholders and suppliers for validation material supply. Supervised QC documentation review and troubleshooting of validation deviations.
Directed QC laboratory validation activities for clients and cross-functional teams. Oversaw validation timelines, protocols, reports, and execution under cGMP. Served as point of contact with subcontractors and clients. Led investigations (OOS, deviations) and implemented corrective actions.
Compiled and maintained interim and final stability protocols and reports for client products and associated raw materials implementation, and equipment qualification. Management of analytical method transfer team NPI. Developed, reviewed and updated Standard Operating Procedures (SOP's) as per USP and Ph.Eur. guidelines. Conducted GAP analysis: Identification of current practices and evaluation of consistency with SOP. Coordination of testing at contract laboratories.
Owned QC projects including method validation/transfer, stability, software implementation, and equipment qualification. Managed a team of analysts, ensuring project KPIs (on-time delivery, right-first-time). Spearheaded audit readiness, prepared documentation for FDA/FAGG inspections, and conducted internal audits. Drove data integrity initiatives, CAPA implementation, and regulatory compliance. Analytical quality by design.
Quality Control Specialist – Romark Belgium (QC testing, equipment qualification, deviations). Development Chemist – Nalco-Champions (project management, ISO/QMS compliance). University Laboratory Assistant – NKUA Athens (method guidance & teaching).
Master's degree focused on analytical physical chemistry methodologies.
Bachelor's degree in Chemistry providing foundational knowledge in chemical sciences.