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. Yourtalents,ideasandpassionare 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.
Must have skills
Experience with some Veeva Vaults or QMS systems for lifescience.
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). (GxP Process)
Implementation and Configuration. Hands-on experience in implementing and configuring Veeva platform 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 Platform. 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.
Desirable 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.
Certifications: Relevant certifications, such as Veeva Certified Administrator or other quality management certifications, may be required or preferred depending on the position and organization
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together.
Interested? Come and join our journey.
So, what's next!
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
Where can I find out more?
Our Social Media:
Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
If you have site, country or departmental social media then feel free to switch any of the above links
AstraZeneca is an equal opportunity employer.
AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law
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.
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.
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