Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities/utilities supporting these operations. Develop and execute process validation protocols for all manufacturing and packaging processes of commercial products Develop and execute cleaning validation/verification protocols for all commercial manufacturing, processing, and packaging equipment. Perform proper and timely sampling of in-process/intermediate products, finished products, rinse water and surface swabbing for testing as outlined by validation/qualification protocols. Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities. Draw conclusions from data, observations, deviation/exception and investigation as to whether process is considered valid Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies. Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner. Ensure protocols, verification, validation plans and summary reports generated during validation/ qualification activities are stored according to procedure. Planning and execution of the calibration master plan and Validation Master Plan. Responsible for compliance with quality integrated system for quality, environment, health and safety in relation with his job and duties. Perform other related duties as assigned to meet departmental and company objectives.
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