Veeva Quality Management System (QMS) Consultant

at  Capgemini

JOB DESCRIPTION:

We are seeking a highly motivated Veeva Quality Management System (QMS) Consultant to support the implementation, maintenance, and optimization of our quality management processes using the Veeva Vault QMS platform. The ideal candidate will have a strong background in quality assurance, a thorough understanding of regulatory compliance, and hands-on experience with Veeva QMS. This role will involve ensuring that quality processes are effectively integrated into all aspects of our operations, fostering a culture of continuous improvement and compliance.

JOB REQUIREMENTS:

• Strong understanding of quality management principles, practices, and regulatory requirements.
• 5+ years of experience in Veeva Suite, Quality Documents, QMS, Vault training.
• 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.

• Assist the sales team with pre-sales technical knowledge and presentations.
• Understand customer requirements and provide sales support.
• Conduct product demonstrations, both online and face-to-face.
• Identify and understand the specific needs of clients.
• Design and develop tailored solutions that meet client requirements.
• Prepare and present proposals to clients.
• Respond to technical and functional product queries during the sales process.
• Work closely with the sales team and other departments to ensure coordination and smooth execution of sales processes.
• Train the sales team on the technical aspects of the product or service.
• Quality Management System Oversight:
  o Manage the lifecycle of quality documents, including policies, procedures, work instructions, and forms within the Veeva Vault QMS.

o Ensure that all quality documentation is compliant with relevant regulations and industry standards (e.g., ISO, FDA, GxP).

• System Configuration and Maintenance:

o Configure and customize Veeva Vault QMS to align with organizational quality processes and workflows.

o Monitor system performance and coordinate with Veeva support for any issues or enhancements.

• Process Development and Improvement:

o Develop, implement, and maintain standard operating procedures (SOPs) and workflows to enhance quality management practices.

o Identify opportunities for process improvement and automation within the quality management system.

• Training and Support:

o Provide training and support to users on Veeva QMS functionalities and quality processes.

Develop user guides and training materials to facilitate effective use of the QMS.

• Regulatory Compliance and Audits:

o Ensure compliance with quality standards and regulations through regular monitoring and assessment of quality processes.

o Participate in internal and external audits, providing necessary documentation and evidence of compliance.

• Data Management and Reporting:

o Maintain accurate records of quality metrics, investigations, and corrective and preventive actions (CAPAs).

o Generate reports and dashboards to communicate quality performance and trends to management.

• Cross-Functional Collaboration:

o Collaborate with various departments, including Manufacturing, Research & Development, and Regulatory Affairs, to ensure alignment of quality processes across the organization.
o Act as a quality liaison to address quality-related inquiries and support investigations.