Management of quality issues of sterile production process on the floor. Correction, review and correct compilation of gmp data. Management of deviation event with evaluation and decision of immediate actions to take and report writing.Staff training with focus on gmp and sterility operating modes. Implementation of documentation, aseptic technology and PPI tools with customer interface.

Internal management e qualification of instrumentation, manufacturing equipment and utilities, calibration of associated control instruments.Relationship maintenance with external companies for the management of outsourcing services (qualification, calibration, drafting of protocols).Deviation writing and analysis. Batch Record Review, internal reporting, logbook management and implementation, draft quality assurance policies and procedures, interpret and implement quality assurance standards, collect and compile statistical quality data. Management of outsourcing services as Pest Control. Analyze data to identify areas for improvement in the quality system, prepare reports to communicate outcomes of quality activities, identify training needs and organize training interventions to meet quality standards, responsible for document management systems, assure ongoing compliance with quality and industry regulatory requirements. Assure training for production operators with GMP impact. ERP software use and management.

Deviation writing and analysis. Batch Record Review, internal reporting, logbook management and implementation, draft quality assurance policies and procedures, interpret and implement quality assurance standards, collect and compile statistical quality data. Management of outsourcing services as Pest Control. Analyze data to identify areas for improvement in the quality system, prepare reports to communicate outcomes of quality activities, identify training needs and organize training interventions to meet quality standards, responsible for document management systems, assure ongoing compliance with quality and industry regulatory requirements. Assure training for production operators with GMP impact. ERP software use and management.

Internship for QA/RA and complianceQuality Assurance: Questionnaire and Quality agreement, Change notification letter, Introduction to Quality System Management (Internal Audit, from customer audit, management documentation) ISO 13485, ISO 9001, CFR title 21 part 820 "Medical Devices: Quality System Regulation".Regulatory Affairs: for medical devices (REACH, ROHS, CP65, CONFLICT MINERALS,ISO 10993,FOOD CONTACT, ETC, FILE 510K, CE MARKING)Customer requests for RA and management documentation

Briefly, we characterized the antibody 4E1, investigating its ability to impair in vivo angiogenesis, and characterizing the recognized epitope. Our results suggest the possible use of this antibody as a novel anti-angiogenic agent and indicate CD93 as a suitable target for anti-angiogenic therapy.ABILITY and SKILLS :Molecular/Cellular Biology Techniques- Cells cultures- Cellular extracts and quantification, DNA extraction- Electrophoresis on polyacrylamide gel in SDS (SDS-PAGE)- Western Blotting- Protein Assay- Cells proliferation/survival/viability Assay- Use of RNA interference technology (RNAi)- Data analysis through specific programs- Production of Lentivirus Particles- Cells Infection- Cells Migration Assay (Burker Chamber)- Immunoprecipitation and Immunoblotting- Matrigel Assay (in vitro)Use of: Fluorescence microscope and optical microscopy, PH meter, chemical reagents at making of chemical solutions

-Cells Proliferation/Survival Assay-Cells Cultures-Western Blotting-Cells protein extracts and quantification-Use of RNA interference technology (RNAi)-Data analysis through specific programs