Sr RBV and VM Technical Business System Analyst

PALNAR is seeking a Senior RBV and VM Technical Business System Analyst to lead system analysis and validation efforts. The role involves managing Veeva validation documentation, collaborating with teams to define system requirements, and ensuring compliance with regulatory standards.

Responsibilities:

• Lead and execute system analysis and validation efforts following CSA and GAMP 5 methodologies
• Handson experience performing Veeva configurations, creating reports and dashboard
• Develop and manage Veeva validation documentation including requirements, test scripts, traceability, and risk assessments
• Collaborate with global and virtual teams to define system requirements and ensure successful implementation
• Perform gap analyses, identify risks, and recommend mitigation strategies to ensure compliance and operational efficiency
• Work closely with IT, Quality, and Business stakeholders to ensure alignment between technical solutions and business needs
• Serve as a subject matter expert in system validation, providing guidance and mentorship to project teams
• Manage multiple initiatives concurrently, ensuring on-time delivery and adherence to regulatory standards
• Support ongoing process improvements to enhance system reliability and compliance posture

Requirements:

• Proven experience in CSA and GAMP 5 implementation
• Strong knowledge of Veeva validation management and Veeva configurations
• Excellent analytical and problem-solving skills
• Strong verbal and written communication abilities
• Demonstrated ability to work effectively with global, virtual teams
• Experience working independently, guiding project teams, and making informed decisions