Daniela Lucà Email & Phone Number

Monza E Brianza - Italia

Direct experience for transfers of oral solids, injectable lyophilized and liquid products including Pre Filled Syringes and Cartridges for European, US, Japanese and ROW markets. Leader of a team which include the following departments: Production, Supply Chain, Quality Assurance, Process and Cleaning Validation, Quality Control, Regulatory Affairs, Industrial Engineering. Provide cross functional leadership on multiple projects, from early technical feasibility evaluation including risk assessments, gap analysis and project planning to manufacturing process transfer, conducted from development trials and engineering batches, through clinical or validation batches until first commercial production support.

Monza E Brianza, Italia

- define process validation strategy (cleaning and process validation) of new drug products (lyophilized, liquids, solid oral forms, packaging);- manage validation activities due to modifications of processes already in place, - prepare Process and Cleaning Validation Protocol, define sampling activities plan and collect, evaluate and summarize the validation results in final reports- prepare "Media Fill" Master Batch Records and protocols- risk assessments- management of Change controls - use of statistical tools

Monza, Lombardia, Italia

As member of QA Department, I was responsible of deviation investigation, CAPA definition and finalization of relative reports. Other competencies were: KPI tracing of Deviation/CAPA, Monitoring of CAPA status, Escalation to Directors/QP all the most critical deviation, Participation in regulatory audit

Milano, Lombardia, Italia

I was responsible of EBR revision and Deviation Report Issuance

Caponago, Lombardia, Italia

My responsability were: EBR revision., discussion with QP and Directors regarding all criticalities occurred during batch manufacturing, deviation investigation and reporting. After QP desposition, I was in charge of the batch release in SAP system.