Job Description

Job Title -Engineer - Veeva QMS/QDocs Specialist Career level - C3 Leverage technology to impact patients and ultimately save lives Do you have expertise in, and passion for, information technology? Would you like to apply your expertise to impact the IT strategy in a company that follows the science and turns ideas into life changing medicines? If so, AstraZeneca might be the one for you! ABOUT ASTRAZENECA AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world\xe2\x80\x99s most serious disease. But we\xe2\x80\x99re more than one of the world\xe2\x80\x99s leading pharmaceutical companies. At AstraZeneca we\xe2\x80\x99re dedicated to being a Great Place to Work. ABOUT OUR IT TEAM It\xe2\x80\x99s a dynamic and results-oriented environment to work in \xe2\x80\x93 but that\xe2\x80\x99s why we like it. There are countless opportunities to learn and grow, whether that\xe2\x80\x99s exploring new technologies in hackathons, or redefining the roles and work of colleagues, forever. Shape your own path, with support all the way. Diverse minds that work cross- functionally and broadly together. About the role 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.
• Deliver training and support to users on Veeva QDocs and QMS functionalities.
• Fix 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 aligns 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.

Apply 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
• Good interpersonal skills with ability to work effectively across team boundaries

WHY JOIN US? We\xe2\x80\x99re a network of high-reaching self-starters who contribute to something far bigger. We enable AstraZeneca to perform at its peak by delivering premier technology and data solutions. We\xe2\x80\x99re not afraid to take ownership and run with it. Empowered with unrivalled freedom. Put simply, it\xe2\x80\x99s because we make a significant impact. Everything we do matters. SO, WHAT\xe2\x80\x99S NEXT? Are you already envisioning yourself joining our team? Good, because we\xe2\x80\x99d love to hear from you! Click the link to apply and we\xe2\x80\x99ll be in touch as soon as we can. WHERE CAN I FIND OUT MORE? Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.