Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety StandardsJob DescriptionSummary:Provides specialized validation knowledge and information, which is directly required to support operations and clients. Completes all protocols related to the validation of equipment, processes, and new products and reviews all finished reports prior to final approval. Ensures documents conform to all Patheon Standard Operating Procedures (SOPs), client requirements, and Good Manufacturing Practices.Essential Functions:Prepare validation protocols, e.g. Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for more complex equipment, facilities, and computer systems.Execute protocol, report deviations, and participate in deviation analysis and resolution.Participate in the data specifications and format review process.Maintain site computerized system inventory list.Conduct 21 CFR Part 11 assessment and Data Integrity assessment for computerized systemsMaintain a safe working environment and report potential hazards.Maintain documentation archiving.Collect, review, and verify data.Maintain cleaning program and trending cleaning results.Coordinate validation activities with other supporting departments.Coordinate samples collection and delivery to labSupport special projects (as required)
Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety StandardsJob DescriptionSummary:Provides specialized validation knowledge and information, which is directly required to support operations and clients. Completes all protocols related to the validation of equipment, processes, and new products and reviews all finished reports prior to final approval. Ensures documents conform to all Patheon Standard Operating Procedures (SOPs), client requirements, and Good Manufacturing Practices.Essential Functions:
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