Company Overview

I2E Consulting Pvt Ltd., a Microsoft gold partner and Great Place to Work certified, was recognized among the fastest-growing US companies in the 2018 Inc 5000. We pioneer digital transformations for Fortune 100 companies, with a focus on the Life Sciences sector. Notable clients include Pfizer, Merck, and ACG. We leverage technologies like AI and cloud computing and offer rich mentoring programs. Our Mumbai-based company ensures work-life balance and leadership opportunities without micromanagement.

About the position

The QMS Consultant will be responsible for ensuring that all quality management processes and deliverables meet the highest standards of quality, regulatory compliance, and alignment with established industry norms. This role involves providing expertise in quality management, identifying and mitigating risks, and ensuring seamless integration of quality systems with Veeva Vault.

Responsibilities:

• Provide subject matter expertise on the Vault R&D migration implementation, including the migration of document content and object data from legacy systems to Vault
• Monitoring and Support: Providing ongoing support to ensure smooth transitions and addressing issues that arise during or after changes
• Ensure all deliverables meet quality standards, regulatory requirements (e.g., GxP, ISO 9001), and align with established processes.
• Classify documents according to quality management standards, defining approval workflows to meet industry best practices.
• Conduct thorough risk assessments to identify compliance gaps, inefficiencies, and areas for improvement.
• Develop a migration strategy ensuring minimal disruption to business operations and regulatory adherence.
• Assisting with training and change management deliverables
• Implement post-migration quality checks, ensuring all documents, workflows, and approvals are functioning as expected in the new system.
• Ensure tools and systems used for quality management seamlessly integrate with Veeva Vault.
• Optimize system functionalities to enhance automation, reporting, and regulatory compliance tracking.
• Develop, implement, and maintain standard operating procedures (SOPs) and workflows to enhance quality management practices.
• Manage change control processes, ensuring smooth transitions with minimal disruptions to quality standards.
• Stakeholder Engagement: Identifying and managing stakeholders affected by changes, ensuring their concerns are addressed and feedback is gathered.
• Develop and deliver comprehensive training materials and sessions to ensure end-users are proficient in Veeva Vault
• Include quality metrics, risks, and issues in status reports, ensuring alignment with senior leadership’s compliance expectations.
• Develop and implement mitigation plans to address identified risks, escalating issues when necessary.

Requirements:

• Strong understanding of quality management principles, practices, and regulatory requirements.
• 5+ years of experience in Veeva Suite, Veeva vault, Quality Documents
• Veeva Admin Certification(Good to have).
• Good Presentation skills for conducting product demonstrations.
• Excellent analytical and problem-solving skills, with attention to detail and accuracy.
• Strong communication and interpersonal skills, with the ability to work collaboratively across teams.
• Experience with GxP and software validation regulations
• Experience with the migration verification process.