n n nThis is a remote position.
KATBOTZ
is seeking a highly experienced
Senior QMS Developer u2013 Complaints
to design, configure, and support
Quality Management System (QMS) Complaint Handling solutions
for regulated industries. The ideal candidate will have deep expertise in complaint management processes, system configuration/customization, and regulatory compliance, particularly in
Life Sciences, Medical Devices, or Pharmaceuticals
.
Role Description
- Veeva development experience in Complaints. This role will be responsible for developing and maintaining solution architecture, system administration, security, and procedures across the Veeva Vault Platform.
- Support all assigned development activities for the Veeva Vault implementation program under the leadership of the client Quality Veeva team.
- Coordinate with Business analysts to outline the business requirements and ensure IT security and Data Integrity requirements are outlined for the solution
- Coordinate with Validation team to prepare the Regulatory Applicability Assessment and Regulatory Risk Assessment documents
- Document specifications and user stories
- Conduct technical feasibility analysis of requirements
- Document System design or configuration specifications document
- Perform Veeva environment management
- Develop custom solutions and integrations to automate workflows, enhance system capabilities, and ensure seamless integration with third-party applications.
Required Skills
- Experience with Configuration and Customization: Setting up and customizing Veeva Vault applications to meet client-specific requirements.
- Experience with Veeva Vault Quality, with a strong emphasis on QMS experience; documented certification and experience in a GxP environment is highly preferred.
- Experience with developing custom solutions and integrations to automate workflows, enhance system capabilities, and ensure seamless integration with third-party.
- Development and Implementation: Building and deploying solutions using Veeva Vault functionalities, including workflows, metadata structures, and security settings.
- Integration: Developing and managing integrations between Veeva Vault and other enterprise systems (e.g., SAP, Salesforce) using technologies like APIs, SOAP, and REST.
- Proficiency in relevant technologies like XML, SQL, APIs, and programming languages like Java and JavaScript
- Proven development of cloud-based solutions
- Familiar with SDLC and the delivery of GxP Validated systems
- u200bVeeva QMS certification is a big bonus
Benefits
- Competitive compensation package
- Opportunities for professional development and career advancement.
- Flexible working conditions, with remote options available.
- Dynamic and supportive work environment.
Equal Employment Opportunity
KATBOTZ LLC is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified individuals, regardless of race, religion, gender, gender identity, age, marital status, national origin, sexual orientation, citizenship status, veteran status, disability, or any other legally protected status. As an organization, we are unwavering in our commitment to maintaining a discrimination-free work environment, and fostering a culture of inclusivity, belonging and equal opportunity for all employees and applicants.n n
