Responsibilities: 

• Conduct validation activities in compliance with Regulatory standards and requirements and Precision Edge Surgical procedures.
• Develop validation documentation as required (e.g. plans, protocols, reports, procedures).
• Execute validation protocols as required (e.g. Equipment IQ/OQ, Process OQ, Process PQ, etc.).
• Prioritize qualification activities in line with the project schedule.
• Coordination, implementation and active participation in the site validation program for product, process, equipment, software, methods, utilities / facilities and cleaning.
• Mapping GxP business processes to identify data creation, flow and controls.
• Evaluate computerized systems with respect to technical controls and requirements for ERES.

• Perform GxP assessments, Electronic Records and Electronic Signatures assessments

Requirement :

Educaton : Bachelor's

Experience : 3-5 years