The Veeva Administrator is responsible for ensuring the Veeva Vault Applications are maintained in a compliant manner
Responsibilities encompass administration of Veeva Vault Regulatory Information Management, document management, training management, EDC, CDMS, eTMF, Quality management and Laboratory Information Management systems
Essential Duties and Responsibilities:
Serves as the Veeva System Administrator responsible for the implementation, IT administrator and ongoing maintenance of the Veeva Vault, including configuration and set up objects for document management workflows, training workflow, QMS workflows, LIMS, and RIMs.
Configure and review workflows with BO/SO and Quality to set up for document management, training management and QMS (Audits, Deviations and Supplier Qualification) modules in Veeva Vault.
Coordinates with business process owners for change control, quality assessment and approval, testing, and deployment.
Develops and implements ongoing training.
Creates and maintains user accounts.
Ensures controls related to approval levels and user access are established and maintained per BO/SO.
Manages changed static data.
Proactively identifies and works to resolve project and system issues.
Ensures Veeva Vault conforms to regulatory requirements.
Oversees and participate in the development of application documentation.
Ensures system workflows and triggers are configured and maintained per intended use of the system as established by business process owners.
Works in coordination with business stakeholders to develop and prepare reports, metrics, and dashboards.
Works closely with various business stakeholders to lead and manage business requirements and system solution delivery.
Supports ongoing maintenance and enhancements/scheduled releases as required.
Assesses changes to the system (e.g. new releases) for business and training impact.
Drive improvement and efficiencies.
Minimum Qualifications (Knowledge, Skills, and Abilities):
Bachelors Degree in a related field plus 5 years of Quality, Regulatory or System Administrator experience, or equivalent work experience is required.
Proven experience in leading and deploying a combination of the following: QMS, document management, Electronic Learning Management System or Regulatory Information Management System.
Experience in a pharmaceutical or any highly regulated environment is preferred.
Knowledge of Quality Assurance/Quality Control Operations and Regulatory.
Experience with system design and development starting from business requirements analysis through implementation and support.
Possess and demonstrate excellent oral and written communication skills, as well as proactive problem-solving, analytical, and multi-tasking skills.
Possess ability to work within a team-based environment while proactively forging positive relationships across all levels of management, departments, supplier.
Quality Systems Experience in a CGMP environment
Excellent written/oral communication skills
Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment
