Job Description
Identifying, planning, and implementation of validation requirements in a GMP environment, including cleanroom, equipment, instruments, and manufacturing or testing processes.
● Preparation of the URS for the equipment, utilities, and facilities.
● Preparation of room datasheets for the facilities.
● Prepare, execute, and completion of OQ, IQ, and PQ protocols.
● Prepare schedule or plan for the requalification of equipment/facilities as per the Impact and risk assessment.
● Prepare a protocol for the requalification and execute it as per schedule.
● Performing qualification tests.
● Process validation and media fill.
● Preparation and execution of process validation, protocols, and report.
● Risk assessment and Impact assessment.
● Applying a risk-based approach to all validation activities.
● Implementation of system impact assessment and component criticality for equipment, utilities, and facilities.
● Statistical analysis and interpretation of test results.
