Alessandra Carvalho Email & Phone Number

Rio De Janeiro, Rio De Janeiro

- Lead, supervise, and execute validation protocols, and reports (DQ, IQ, OQ, PQ, Risk Analysis, Requirements Traceability, etc), according to schedule.- Execute planning, and controlling calibration. qualification, and preventive, and corrective maintenance execution.- Ensure compliance to regulatory authorities, company policies, and Good Management Procedures (GMP).- Supervise, and manage maintenance contracts, teams, documentations and vendor visits.- Negotiate resources (material, personnel, deadlines, etc.) for qualification, and maintenance execution.- Provide support, and participate in planning, and monitoring qualification activities.- Execute operations monitoring (HVAC, rooms, cold chambers, etc) though supervisory system- Supervise, and approve Clean Room Certification.- Execute, and revise Standard Operating Procedures (SOPs), and perform personnel training.

Rio De Janeiro

- Lead, create, and execute risk based qualification of Equipment, Utilities and Systems (DQ, IQ, OQ, PQ protocols, and reports, Risk Analysis, Requirements Traceability (FMEA), etc).- Support FAT/SAT and commissioning of equipment, and computer validation.- Supervise, and approve of Clean Room Certification (HVAC certification).- Advise project teams, on support documents, such as User Requirement Specification (URS), flow diagrams (P&IDs), etc.- Support of continuous improvement on process, and projects.- Create, and participate in project planning, scheduling, and tracking.- Develop, support, and implement operational procedures (SOP) to comply with corporate and industry standards.- Support qualification training for operation employees.- Ensure compliance with domestic and international health authorities requirements and with Good Manufacturing Practices (GMP).- Provide technical support to production, engineering, and change management (TCM), deviations, and CAPA.- Represent Rio's site on Global Community in regards to Qualification, Engineering, and Supplier efforts.

Rio De Janeiro

- Create Equipment, Utilities and Systems DQ, IQ, OQ, PQ protocols, and reports.- Supervise, and revision of Clean Room Certification (HVAC certification).- Support of continuous improvement on process, and Validation projects.- Develop, and support procedures in order to comply with corporate, and industry standards (SOPs).- Support qualification training for operation employees.- Ensure compliance with domestic, and international health authorities requirements and with Good Manufacturing Practices (GMP).- Suport Production, and Engineering Departments as well on change management, deviations, and CAPA efforts.- Develop, and track Validation Master Plan schedule.

Rio De Janeiro E Região, Brasil

- Production equipment preventive and corrective maintenance planning and controlling (HVAC, packaging lines, filling, tableting, weighing, etc).- Department point of contact for disclosure of departmental information.- Supervise, and support of suppliers and third-party supervision.- Management of work orders, and spare parts on SAP® system.

Rio De Janeiro E Região, Brasil

- Utilities equipment preventive and corrective maintenance planning and controlling (HVAC, pharmaceutical water generation, distribution and operation, boilers, steam, compressed air system, and chilled water).- Assiste on the surveying and control of monthly consumption of inputs (water, and steam).- HVAC monitoring using Building Maintenance System (BMS) software.- Data analyses, and support of predictive maintenance.

Master Of Business Administration - Mba, Production And Maintenance Strategic Management

University Extension, Air Conditioning Engineering (Hvac)

Qualification to work in basic and executive projects; Knowledge update in the area of ​air conditioning engineering; Complementation.

Master Of Business Administration - Mba, Project Management

Bachelor'S Degree, Mechanical Engineering

Exchange Program