Validation Analyst

Description

• Lead/support validation efforts and deliverables for systems used for Clinical, Pre-clinical, global medical and Finance/Operations with minimal oversight.
• Develop the validation testing strategy for large and medium sized projects and develop the overall Validation plans and timetables.
• Create and execute validation test scripts and document test results in accordance with company standards.
• Review and evaluate validation assessments for application systems/projects.
• Ensures that validation project documentation is in compliance with company policies and procedures
• Prior Experience with validation of Clinical systems preferred.
• Require prior experience in creating Change Requests, Developing Validation Plan, test scripts, Summary Reports, Traceability Matrix and other validation project documents in the Pharmaceutical industry preferred.
• Create and execute validation test scripts and document test results in accordance with standards (Manually or in Quality Center)
• File validation documentation within following Quality Assurance Library guidelines.
• Ensures that project documentation is in compliance with policies and procedures
• Provide monthly reports on of validation activities in the organization to Validation SME and/or Manager

• 3 to 5 minimum years of experience in the Pharmaceutical industry.
• Excellent verbal and written communication skills, Customer Service Focused; Information Technology background, experience within a Quality/Regulated environment including SDLC.
• Strong interpersonal and technical writing skills and the ability to interact across divisional boundaries.
• Ability to manage multiple tasks and projects simultaneously, and to prioritize work, goals and tasks per the divisional and corporate objectives.
• Ability to report results clearly and concisely.
• Sound reasoning and ability to quickly analyze and solve complex problems.
• Must be capable of continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
• Experience with Quality Center (HP Quality Center) preferred.
• Associate Degree minimum or equivalent combination of education and work experience.