To perform QA review of assigned qualification and validation lifecycle documents, including:
Validation Master Plans or local validation plansUser Requirement SpecificationsRisk assessmentsDesign Qualification, Installation Qualification, Operational Qualification, and Performance Qualification protocols and reportsProcess Performance Qualification and process validation protocols and reportsCleaning validation documentationAseptic Process Simulation / Media Fill documentationComputerized system validation packagesQC Chemistry and Microbiology qualification or requalification documentsEquipment, utilities, facilities, and engineering qualification documentationRequalification, revalidation, and lifecycle review documentsTo verify that assigned documents include clear scope, predefined acceptance criteria, traceability to user and GMP requirements, defined responsibilitie...