years of experience in Computer system validation in Utility/facility Automation design with solid understanding of Good Manufacturing Practice (GMP) regulations
Solid understanding of the variety of these types of computerized systems to qualify systems which impact cGMP operations using a risk based methodology
Assist with the development of system requirements and specifications to ensure requirements that are testable and CFR Part requirements are met
Develop CFR Part 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.
Good Experience in Digital Validation Platforms like Kneat or similar tools.
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.
Able to work collaboratively and in a client focused environment. Have the highest standards for quality, accuracy, and professionalism.
Be highly motivated, organized, and able to manage priorities. Have excellent communication, presentation, and interpersonal skills.
