Dealt with the roll out of an updated CAPA program in which a new process has been outlined. Develop controls and work on making more efficient and standardizes in managing CAPA.Intensive use of Excel for reports based on SAP exported data as well as to aid the analysis of data provided.Review and update the report templates for the Annual Product Reviews (APR). Analyze stability data and assay values in order to determine release and alert limits. Alert limits… Show more Dealt with the roll out of an updated CAPA program in which a new process has been outlined. Develop controls and work on making more efficient and standardizes in managing CAPA.Intensive use of Excel for reports based on SAP exported data as well as to aid the analysis of data provided.Review and update the report templates for the Annual Product Reviews (APR). Analyze stability data and assay values in order to determine release and alert limits. Alert limits were provided with the use of statistical software. Show less

Intensive use of Excel for reports based on SAP exported data as well as to aid the analysis of data provided.Review and update the report templates for the Annual Product Reviews (APR). Analyze stability data and assay values in order to determine release and alert limits. Alert limits were provided with the use of statistical software.

The following is a high level summary of these roles:Role #1: Equipment Change ControlExpertise in the engineering and maintenance fields to deal with equipment change controls. A comprehensive review of change controls to assure a more robust change control was issued. Developed the Change Control determination worksheet. Developed the Impact Assessment procedure and form. Approver for Quality Assurance Preventive Maintenance Plans.Role #2: Material Change… Show more The following is a high level summary of these roles:Role #1: Equipment Change ControlExpertise in the engineering and maintenance fields to deal with equipment change controls. A comprehensive review of change controls to assure a more robust change control was issued. Developed the Change Control determination worksheet. Developed the Impact Assessment procedure and form. Approver for Quality Assurance Preventive Maintenance Plans.Role #2: Material Change ControlDeveloped a process to recognize when Regulatory Affairs Filing Determination was needed.Developed a Job Aid to review RECAPS and Packaging Specification change controls. Reviewed and updated the Material Change Control procedure.Work aggressively in conjunction with others to reduce the amount of past due changes.Role #3: Process Change ControlThis included the review and closure of PEM, SCAF, NPD, SPINs and other process related cases. Show less

Provide validation and maintenance expertise for manufacturing equipment such that these are in compliance with FDA’s current good manufacturing practices. Develop and issue Installation Qualification Protocols to document the installation and operation of the equipment in accordance to Corporate Project Plan.Prepare robust test cases and documentation forms for the protocols activities.

Technical Operation Validation Specialist (Substance P: Special project)In charge of preparing Operational Qualification Protocols and Addenda as required for a new process that was to be validated. PRV Quality Control ManagerIn charge of the certification of the Pressure Relief Valve shop and to maintain to current revision the Quality Control Manual for the shop.Compliance Supervisor In charge of the area that has controlled documents and that issues schedules for… Show more Technical Operation Validation Specialist (Substance P: Special project)In charge of preparing Operational Qualification Protocols and Addenda as required for a new process that was to be validated. PRV Quality Control ManagerIn charge of the certification of the Pressure Relief Valve shop and to maintain to current revision the Quality Control Manual for the shop.Compliance Supervisor In charge of the area that has controlled documents and that issues schedules for several plant programs.Installation Qualification Protocol Developer Over 120 Installation Qualification Protocols covering the main and ancillary equipment were prepared and executed.System Administrator for Computerized SystemSoftware such as FAMIS, MAXIMO and Calibration Manager were validated in the site prior to use. Maintenance Planner 1991-1992In charge of planning tasks to be performed for pharmaceutical plants and API plants. Issued work orders and requisition for materials for jobs in progress and for jobs to be planned.Maintenance Supervisor 1989-1991In charge of a three-shift packaging line mechanic for the packing lines. Show less