Senior Systems Administrator - Veeva
49 Stevenson | Suite 1100 San Francisco, CA 94105 US
Job Description
POSITION SUMMARY:
The Senior Systems Administrator is responsible for administration and maintenance of the electronic document management system (EDMS), Vault Training (VT), QMS, and Regulatory Information modules including user management, user training, system maintenance, and reviewing and maintaining system validation, etc. The Senior Systems Administrator liaises with Human Resources (HR) for the onboarding and processing of documentation of new personnel according to Company policies and procedures. This role also provides quality system support to the Quality, Clinical, Regulatory, and Product Development departments as needed.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Serves as a “Vault Owner” and System Administrator for the Veeva EDMS and related modules including user account provisioning, administration, and deactivation
- Participates in the implementation and continuous improvement of the system, including the design, testing, and deployment of system configurations and updates to address business requirements
- Supports system validation activities, e.g., reviewing validation documentation, executing UAT and validation protocols, and authoring validation reports
- Keeps abreast of release upgrades, new and changing features/functions, and planned maintenance dates
- Assesses the impact of Veeva system upgrades and evaluates the adoption of feature enhancements
- Troubleshoots operational and configuration issues
- Conducts training to end users for the Veeva platform
- Administers and supports the management of company training records in the Veeva EDMS
- Liaises with HR to obtain Job Descriptions and Curriculum Vitae for company personnel
- Supports the management of document control functions (e.g., DCR/DCC initiation, routing documents, Periodic Review, etc.)
- Supports Quality Assurance activities across the organization, including:
- The development, review, and approval of company policies and procedures
- The development and presentation of content on GxP, industry, and/or Veeva topics
- The administration and tracking of change controls, deviations, and CAPAs
- Providing QA/QC support for Clinical, Regulatory, and Product Development teams (e.g., labeling review, TMF review, DHF design)
- Supporting internal and regulatory audits and assisting in the development and implementation of inspection readiness activities
ESSENTIAL SKILLS & QUALIFICATIONS:
- Associates or higher degree in life science, IT/Computer Science, Quality Management, or related field, or equivalent qualifying work experience
- Work experience (> 5 years) maintaining computer systems in a GxP regulated industry, or relevant coursework
- Experience administering an electronic document management system (EDMS)
- Familiarity with software Quality Assurance and SaaS Computer System Validation (CSV) in a regulated environment
- Knowledge of document control fundamentals, Quality Systems and GMP requirements
- Strong technical acumen with an eagerness and curiosity to pick up new technologies
- Proficiency in Microsoft Office applications and Adobe Acrobat
- Fluency in English with strong written, verbal, and interpersonal communication skills
- Ability to work independently with minimal supervision and as part of multi-departmental project teams
- High level of attention to detail and ability to organize work efficiently
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