Experience

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  Sterling s.p.a.

  Jun 2017 - Sept 2017

  Analytical chemist

  Use, management and processing of data acquired by the HPLC instrument, Malvern Mastersizer 2000 (PSD analysis); Daily and periodic checks of analytical balances.

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  Coc farmaceutici

  Jun 2019 - Nov 2022

  Quality assurance, qualification and validation specialist

  • Issue of calibration reports of measuring instruments (calipers, chronometers, temperature and humidity data-loggers, particle counters, level and pressure probes, standard masses, static and dynamic scales).• Issuance and review of qualification protocols and reports of:o production and warehouse equipment (dissolvers, autoclaves, incubators, refrigerators, cold rooms, HVAC, laminar flow hoods);o pharmaceutical industry plants (PW water, PPI, steam and compressed air, biodecontamination systems); - Filling line and secondary packaging machines;o controlled contamination environments;• Planning and organization of calibration, qualification and validation activities and coordination of internal and external personnel for their implementation.• Management and archiving of calibration, qualification and validation documentation.• Drafting of Standard Operating Procedures and FORMs for the use, calibration, qualification and validation of instruments, equipment, plants and production lines and execution of training for the personnel concerned.• Supervision of FAT, SAT and initial IQ/OQ qualification tests for newly installed equipment and machines.• Management of data integrity and CSV of production systems.• Issue of annual calibration and qualification plans and review of workshop documents• Support in investigations in case of deviations.• Support in inspections relating to plants, processes and environments. Show less

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  Pqe group

  Jan 2023 - Jun 2024

  C&q/gmp compliance consultant

  o Writing of the Validation Plan prepared for the systems subject to qualification.o Execution of "Risk Analysis", “Component criticality analysis” and “Data Integrity Risk Assessment”.o Perform the Design Review before the testing phase of the validation lifecycle.o Reviewing FAT protocols and evaluate them that there are compatible with the quality requirements requested by GMP.o Writing and Review installation and operational qualification protocols creating related Installation/Operational Qualification Reports (IQR, OQR, IOQR as applicable) summarizing the results of qualification activities executed by vendors, across systems baseline of mandatory tests to fulfil regulatory expectations, and evaluating adequacy, completeness and consistency of raw data and results.o PQ protocol writing, protocol execution and protocol revision respectively.o Traceability Matrix: charge of drafting the relative traceability matrix including all the tests carried out during C&Q activities Validation Reports articulated on two levels (VPP level and VP level) o Risk Assessment criticality alarms and machine parameters: prepare a risk assessment with focus on criticality alarms and machine parameters according to SOP. Show less

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  Romaco group

  May 2024 - now

  Documentation specialist