Develop validation protocols
Develop, and prepares validation protocols to challenge the all types of processes for validation of manufacturing and packaging processes, as well as cleaning processes.
Design, develop, and prepare of validation protocols to challenge both mechanical and electrical, controls, and pneumatic processes for qualification of facilities and utilities installation and operation.
Execute and/or assist in execution of validation protocols which consists of taking finished product and bulk samples, swabbing equipment surfaces for cleaning evaluation, and evaluating packaging processes. Equipment qualification execution entails analyzing equipment performance against stated performance criteria
Review analytical data (chemistry and microbiological) in support of validation efforts.
Compile/Analyze analytical validation data and test results and prepare documentation for FDA compliance.
Provide necessary evidence to support proof that manufacturing, packaging, and cleaning systems/processes consistently result in products or processes that meet established specifications and quality standards.
Attend meetings with production, packaging, engineering, quality assurance and research and development personnel to obtain the necessary information for protocol preparation.
Coordinates validation activities associated with validation protocols with all support groups (Quality Assurance, Research and Development, Operations, Quality Control, Project Management, Engineering)
Review detail of change activities for equipment qualifications and decides on revalidation requirements.
Perform additional special projects as needed to support product release and/or technical service investigation activities