We are seeking a talented Sr. CSV consultant to develop, review and lead activities related to CSV data integrity and CAPA working with staff at a client site. This also involves writing test cases and summary reports.
Responsibilities:
• Review and evaluate Data Integrity issues including SOP edits, supplemental validation testing, working with vendors/ IT to implement security patches/ upgrade systems, strategies, policies, standards, processes, SOP's and other documents and as needed.
• Develop and perform diverse Validation activities, documentation requirements and reports including plans, risk assessments, function requirements, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation and compliance reviews.
• Develop and complete deliverables as needed and in line with project/business objectives.
Requirements:
• College degree or equivalent work experience; 7 plus plus years of CSV experience including experience with analytical Lab systems and Data integrity
• Effective organization, communication and interpersonal skills and the ability to manage priorities in a time sensitive environment.
• Technical Lead or Project Manager experience highly desirable.
• Proficiency using computer software and systems related to performing CSV activities.
• Knowledge in GAMP, FDA, CFR 211 and related regulations and standards
