Consultant - Application Engineer - Veeva QDocs and QMS Specialist

Job Title: Consultant - Application Engineer - Veeva QDocs and QMS Specialist

Career Level - C3

Overview

AstraZeneca hires people with a passion to make a difference in the health of millions of people globally. Your expertise, coupled with AZ’s advanced technologies and collaboration with thousands of innovative scientist, chemist and analyst will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people to live better and healthier. Interested in learning more about life at AstraZeneca a world leading pharmaceutical company? Start here.

Job Summary

A Veeva QMS/QDocs Specialist is responsible for implementing, maintaining, and optimizing Veeva's Quality Management System and Quality Document solutions for life sciences organizations. This role typically involves working with cross-functional teams to ensure compliance with industry regulations, streamline quality processes, and improve document management.

The main responsibilities of the role:

• System Administration: Manage and administer Veeva QDocs and QMS platforms.
• Configure and maintain system settings, user roles, and permissions.
• Document Management
• Organize and oversee the creation, review, approval, and archiving of quality documents.
• Ensure compliance with regulatory standards and internal quality procedures.
• Provide training and support to users on Veeva QDocs and QMS functionalities.
• Troubleshoot system issues and assist with problem resolution.
• Collaborate with cross-functional teams to optimize quality processes.
• Identify areas for improvement and implement enhancements to streamline document management and quality assurance.
• Compliance and Auditing: Ensure documentation complies with industry regulations (e.g., FDA, ISO).
• Prepare for and support audits and inspections.
• Reporting and Analytic: Generate reports and analyze data to assess document and quality system performance.
  Utilize data insights to drive continuous improvement efforts.
   

     Essential Experience: (Must have skills)

• Veeva QMS/QDocs Expertise: Proficiency in using the Veeva QMS and QDocs platforms is essential. This includes a deep understanding of their functionalities, configuration, and administration.
• Quality Management Knowledge: Strong knowledge of quality management principles and practices, especially in the context of the life sciences industry.
• Regulatory Compliance: Experience in ensuring regulatory compliance within the life sciences sector, including an understanding of quality and compliance standards like Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
• Implementation and Configuration. Hands-on experience in implementing and configuring Veeva QMS and QDocs to meet the specific needs of an organization. This may involve setting up workflows, document templates, and user roles.
• User Support and Training: Experience in providing user support and training to ensure that staff can effectively use the Veeva QMS and QDocs systems. This includes addressing user issues and questions.
• Quality Process Improvement: Ability to work with cross-functional teams to improve quality processes, streamline workflows, and optimize document management.
• Documentation Management: Proficiency in document management best practices, including version control, document approval workflows, archiving, and audit trails.
• Certifications: Relevant certifications, such as Veeva Certified Administrator or other quality management certifications, may be required or preferred depending on the position and organization

Educational Qualifications

UG - B. Tech /B.E. or other equivalent technical qualifications

  Personal Attributes:

• Keen to acquire new skills and work on new technology products
• Must participate on call rotation with off hours support responsibilities
• Ability to work independently, as well as in a team environment
• Logical mind with keen analytical skills
• Clear and concise communicator, in born written and verbal
• Ability to respond well to pressure
• Strong interpersonal skills with ability to work effectively across team boundaries

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.