Location: Remote(INDIA/USA)

Job Description:

Functional requirements and documentation of detailed business system processes

Impact assessments of changes, both system and overall end-to-end processes, including data integrations, system to system integrations or Vault to Vault integrations (including cross-links, connectors) where applicable

Workflow scenario (positive and negative) testing, including technical and end user testing

Application configuration, deployment and documentation, computer system validation documentation

System support management, including coordination of application configurations performed by service and support vendor(s)

Support and promote an iterative, incremental system enhancement and maintenance methodology, optimizing the vendor’s platform releases along with Apellis application release schedule

End user support, which may include report and dashboard development

Key Responsibilities:

Coordinates support activities across internal and external personal, including managed services vendor(s).

Identify and troubleshoot procedural, operational and configuration issues.

Provide IT system support, including vendor operational and maintenance and oversight to the vendor’s SLAs.

Leverages standard best practices for multi-tenant web-based solutions and IT Computer System Validation artifacts:

Participates in impact assessments, user requirements and functional specifications, test scripts, and the review of any test or validation plans and corresponding summary reports

Provides supporting artifacts to computer system validation and change control documentation including Platform Releases and Vault Application Releases

Skills, Knowledge Abilities:

Self-motivated and passionate to learn and adopt new technology and methodologies

Team-oriented and generous in sharing knowledge and enabling others

Reliable, consistent, and proactive

Capable of day-to-day problem solving and taking responsibility for decisions

Customer Service oriented with attention to detail and quality

Must be able to effectively prioritize and plan. Ability to address multiple projects and adapt to changing priorities.

Strong verbal and written communication skills

Ability to communicate and work independently with cross-functional/inter-departmental teams and within the framework of the IT organization.

Proficient in Microsoft Word, Excel, PowerPoint and other applications.

Experience:

Experience in supporting one or more Veeva Vault Applications: Clinical (eTMF, CTMS), RIM (Submissions, Registrations), Quality (QDocs, QMS). Veeva Vault Administration Certification is required (i.e. Platform White Belt or higher/specific).

Experience with GxP guidelines, Computer Software Validation (CSV), and IT SDLC

Experience working in a GxP environment(s) (FDA, EU, MHRA) is required. Strong understanding and working knowledge of FDA 21 CFR Part 11, ICH E6.

Bachelor’s degree in computer science, technology, operations, or related disciplines required.

5+ years in a pharmaceutical/biotech or related environment required