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.

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.

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.