Job Description

• Generate Qualification Periodic Review Assessment to Manufacturing, Packaging Equipment classified, and GMP utilities according to frequency as determined by system classification and risk as defined in procedures and policies
• Review system classifications and risk of equipment and utilities and update as needed
• Perform Periodic Monitoring of manufacturing equipment, packaging equipment, and utilities to ensure that the equipment is maintained in a validated state
• Provide support to the Process owner to review the validation life cycle to ensure the equipment compliance with regulatory and company policy requirements and address mitigation actions as they arise
• Ensure that the periodic review plan is achieved and on track and collaborate with stakeholders on plan attainment
• Address the periodic review reports
• Review and update procedures, managing and collaborating on the procedural documentation with the required stakeholders, as applicable
• Revise quality records including Deviations, Change Control, and CAPAs, and determine the cumulative impact on equipment and utilities’ validated state
• Support the design and implementation of a robust and compliant framework of CGMP policies, procedures, and processes

Qualifications:

• B.S. degree required in Engineering or Science discipline with a minimum of 2 years of experience in pharmaceutical
• Knowledge of validation principles, standard concepts, practices, procedures, and requirements in GMP-regulated environments
• Knowledge of QA terms, tools, and methodologies.
• Working knowledge of MS Office
• Knowledge of GMP and environmental regulations applicable to the pharmaceutical Industry.