Rhenna D.

Implemented the ISO 13485 Quality Management System and an Environmental Management System adhering to ISO 14001. Established the OHS aspects under ISO 45001 and the CPAKB System for Good Manufacturing Practices in medical devices. Managed human resources and analyzed coating solutions and solvents, overseeing their alignment with production needs. Coordinated operators and laboratory staff to conduct Cleaning Area Mixing as per the defined schedule and ensured compliance with SOPs for coating solution analysis. Reviewed analysis data for inclusion in the monthly summary report and communicated findings to section heads or laboratory managers. Evaluated chemical usage in the laboratory and maintained laboratory instruments including Gas Chromatography, Oven, Brookfield Viscometer, density meter, and pH Meter. Compiled monthly reports on chemical consumption for production and facilitated preventive maintenance and instrument calibration, while checking and correcting laboratory documentation as necessary. Supervised the implementation of waste management and quality management systems, including adherence to 5R principles in the laboratory area.

Conducted analysis of raw materials, performing % solid analysis, Titrimetric analysis, viscosity tests using a Brookfield viscometer, and IR spectrometry. Measured melting and boiling points and analyzed % water through titration. Also, carried out physical analysis including evaluation of color, odor, and visual characteristics. Entered data into the system using computerized methods.