Veeva QMS Consultant

Experience- 5+ years

Work timings – 5.30 p.m _2.30 a.m (IST)

Contract – 3 months

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.

● 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 is required.

● 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