Saira Pamela D.

🔲𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵 ⤢Development of Real-time Simulation from Electric Motors through the 𝘏𝘢𝘳𝘥𝘸𝘢𝘳𝘦 𝘪𝘯 𝘵𝘩𝘦 𝘓𝘰𝘰𝘱 𝘔𝘦𝘵𝘩𝘰𝘥𝘰𝘭𝘰𝘨𝘺. ⤢Design of embedded systems. ⤢Hardware platform creation.

🔲For a Project at German Plant Beiersdorf ⤢Lead Supervision of implementation from a Automation system. ⤢Manage the execution of Automation works supported by RA. ⤢Technical advice, design, performance of control engineering documentation, Validation protocol and FAT execution.

🔲For a Project at British Plant Unilever ⤢Quality Management and assurance, validation, commissioning at major investment of the new multinational. ⤢Lead the control quality and document from project. ⤢Closing deviations, addressing complaints, monitoring change control, implementing CAPAs, developing procedures, etc.

🔲For a Project at German Plant Beiersdorf ⤢Commissioning Supervision of an Expansion Project. ⤢Manage the execution of Mechanical works supported by RA. ⤢Technical advice, design, review of the Commissioning Plan, Protocols and Reports.

🔲For a Project at Swiss Plant Nestlé ⤢Lead technical supervision of Automation works supported by RA. ⤢Planning and negotiation with specialized suppliers. ⤢Management of control logic, communication protocols, circuits and electrical diagrams. ⤢Commissioning and validation of Automated control and linked robots to areas, equipments and systems.

⤢Manage implementation of Lean manufacturing, Six Sigma, continuous improvement, 8D, SCRAP reduction. ⤢Analysis and monitoring of AQL indicators, Cpk, PDCA cycle, CAPAs, RCA, time and movement studies. ⤢Identification of opportunities to Automate Processes.

⤢Manage the system for computerized systems validation based at GAMP 5. ⤢CSV, data integrity, V-model from SDLC, RA through AMEF, ALCOA, check the Control and the Automation associated with GxP processes. ⤢Satisfactory defense of computerized systems to obtain the health license issued by Cofepris.

🔲For a Project at Sophia and Carbel Laboratories ⤢Coordinate, plan and monitor projects for compliance to 21 CFR part 11 referenced to Automatic Systems. ⤢Process Automation Infrastructure Qualification at Laboratorios Sophia. ⤢CSV of specialized laboratory equipments that manage GxP processes at Grupo Carbel.

🔲For a Project at Boehringer, Beiersdorf and PiSA Laboratories ⤢DQ/IQ/OQ/PQ Qualification and Commissioning from Tanks for Bioreactions and services of purified water and pure steam at German Plant Boehringer Ingelheim Vetmedica. ⤢Manage DQ/IQ/OQ Qualification, AMEF, FAT, SAT and Commissioning from a System for Bulk-tanks, purified water, CIP cleaning system and compressed air to double production at German Plant Beiersdorf Manufacturing. ⤢PQ Qualification from HVAC system, check Simulated Filling and Coordinate the execution of Process and Cleaning Validation at Laboratorios PiSA. Audited by INVIMA, ANVISA, FDA and Cofepris. ⤢Experience in Plant Start-ups and qualified in recovery technique for cleaning. ⤢Help in executing technology transfer. 🔲For a Project at Pfizer and Apotex Laboratorys — 2022 ⤢Technical advice about CSV of PW system at American Plant Pfizer. ⤢CSV and DQ/IQ/OQ/PQ Qualification from a PW System at Canadian Plant Apotex.

🔲For a Project at Portuguese Plant Colep ⤢Design and review of the Validation Master Plan, of Validations and Qualifications reports for this supplier of manufacturing of P&G. ⤢GMPs verification audit to comply with FDA regulation. ⤢Design of templates, formats, procedures, policies and work instructions in accordance with the QMS.

📌Professional trained to develop Pharmaceutical technology and solve problems in the design and production of high-quality DRUGS, can also design equipment, plan production, estimate costs, innovate new products, implemented processes and formulations. Engineer with knowledge about: ➠Pharmacovigilance➠Pharmaceutical Legislation➠Chemical synthesis➠Formulation➠Validation➠Stability studies➠Physicochemicals analysis➠Design of Pharmaceutical plants➠Bioreactors➠Biotechnology➠Microbiology➠Bioprocesses➠Analytical Chemistry➠Technology transfer.

📌Professional trained in mechanics, electronics, computing and Control systems who, through the design, planning and development of controllers, communications, electrical circuits, signaling structures, y programming logic, is capable establish AUTOMATED processes. Engineer with knowledge about: ➠Instrumentation➠Computer vision➠Design of Automated Workstations➠Controllers➠Systems SCADA and embedded➠Communication Protocols➠Motors control➠PLCs programming➠Robotics➠Microcontrollers➠Design of electrical circuits➠Neural networks.