Technical Analyst/ CSV

• 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.

Automation, Ontwikkeling, Operations, Operations, Design, Manufacturing, Validation, Systemen