• US Citizen

• Green Card

• EAD (OPT/CPT/GC/H4)

• H1B Work Permit

• Corp-Corp

• W2-Permanent

• W2-Contract

• Contract to Hire

• Consulting/Contract

• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 27th Dec 2023

 IT validation documents for hardware and software

-- Complex business requirements, including diagrams as needed

-- Standard operating procedures and IT System Guides

-- Software test cases, scripts and reports, included but not limited to UAT, IQ, OQ

-- Additional documentation upon request

- Gather, analyze, prioritize, and manage technical business requirements

- Engineer and test processes, and re-engineer and re-test as needed

- Manage document review and approval workflows

- Perform system administration duties as needed to support the implementation, configuration, setup and validation of GxP hardware and software

 

Requirements

- Core Experience

-- 10 years’ demonstrated experience as a Business Analyst gathering and managing business requirements, authoring SOP's, GxP validation documents and IT System Admin Guides, and writing test scripts, executing tests (UAT, IQ, OQ) and writing test reports

-- 5 years’ experience with GXP validation documentation (including IT System Administration Work Practices) in a life science setting

-- Thorough understanding and experience with document review and approval workflows, and global electronic document management systems

-- Proven aptitude for creating and nurturing trusted relationships with colleagues from IT, business and lab staff at all levels of the organization third-party vendors

-- Familiar with data integrity and archiving

-- Demonstrated knowledge and experience working as a system administrator on Windows workstations/servers reviewing system logs, services, and settings with asset lifecycle management and environmental monitoring systems

-- Solid understanding of and experience with Agile, Scrum, and Kanban concepts

-- Expertise in CFR Part 11/GxP software qualification.

-- Solid understanding of data management and integrity best practices for GxP hardware and software systems

-- Excellent oral and written communication skills

-- Ability to build trust with business, lab and IT stakeholders at all levels of the organization

-- Strong presentation skills

 

- Nice to have

-- Hands on experience AWS as backend/storage

-- Experience with OpenLab, Veeva Quality Docs, MS ALM and/or SAP

-- Experience working as a system administrator on Windows workstations/servers reviewing system logs, services, and settings with asset lifecycle management and environmental monitoring systems

 

Accountabilities

- Manages requirements gathering, prioritization and negotiation with business stakeholders to ensure the total solution delivered meets or exceeds expectations

- Analyze complex business problems

- Author IT validation documents for hardware and software, manages document review and approval workflow

- Work with the business to define validation scope and set priorities.

- Perform system administration duties as needed to support the setup, maintenance, management and validation of GxP hardware and software

- Manage and track document creation, review, and approval workflows for GxP and non-GxP systems, including but not limited to lab systems, hardware, and software

- Implement and manage best data integrity, resiliency (backup, restore and archive) and audit trail practices across hardware, on prem software and enterprise systems

- Create and manage audit trails

- Perform annual account reviews, periodic reviews

- Perform GMP data quality assessments and manage deviations

- Maintain and influence business process design

- Conduct feasibility studies and draft business cases to understand and validate business needs

- Write test cases and scripts, execute tests (UAT, IQ, OQ) and write reports manually and in MS ALM

- Improve operational and technical processes and practices using knowledge of business operations and Business Process Mapping to articulate business and data flows

- Ensure delivered solutions are compliant with associated federal regulations (GMP, GxP)

- Creating and nurture trusted relationships with colleagues from IT, business and lab staff at all levels of the organization third-party vendors

- Learn and become proficient in relevant IT processes; including but not limited to change management, technical operations, lab technical support