Validation Analyst

Responsible for implementation, and effectiveness of Validation strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives.

Summary: Plans, coordinates and directs activities concerned with DDi QMS, compliance related activities (ICH, 21 CFR, GPDR etc), and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards. Accountabilities Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met Evaluate proposed changes to validated computer systems and recommend level of validation activities required Identify and qualify all computer systems which impact cGMP operations using a risk based methodology Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans Execution of validation plans and validation documents Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents. Work closely with Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systems A complete system life cycle approach as part of a Quality Management System (QMS), from concept to retirement. Ability to write Validation plan, Risk assessment, Data management qualification Protocol and report, Operation qualification Protocol and report ,Traceability Matrix ,Validation summary report . review, root cause analysis, and corrective and preventative actions (CAPA) Experience in execution of IQ/OQ/PQ protocols. Implementation of quality systems in line with SDLC requirements and developing Validation Risk Assessment plan Summary Reports. Participation in implementation of 21 CFR Part 11 - Electronic Record and Electronic Signature requirements Participation in creation of SOPs, Validation Plans, and software inspection/audits.