Description

• Write Impact assessment of the given equipment that uses the failure mode and effect analysis (FMEA) approach to assess the potential impact of residues that may reside on equipment used to manufacture components.
• Evaluate the cleaning validation, facilities/ utilities qualification, equipment qualifications and Test method validation records to ensure compliance with FDA regulations and current procedures.

• Extensively involved in the cleaning validation projects in a consent decree environment for facility certification.

• Author, review and approve cleaning validation technical reports, protocols, validation master plans and batch records for production equipment and processes.

• Identify deviations from established product or process standards and provide recommendations for resolving deviations.

• Ensure that validation records are accurate, complete with the corresponding objective evidence to support the validation performed

• Make recommendations to solve quality issue found in validation records.

• Perform characterization study for the existing cleaning process.

• Calculate and set the equipment acceptable limits for the equipment

• Train line operators to identify conforming / non-conforming product.

Calculate and set the Acceptable level for the given equipment based on the dimensions and the median Lethal dose 50 (LD50) value of the potential residues identified in the volume and on the surface of the equipment.

Bachelor’s degree:Mechanical Engineering or related field.