Support new and existing applications in a FDA auditable compliant manner used to support regulated business functions and processes.
• Lead, develop and executes the computer system validation and change control lifecycle activities. Documenting all system updates per governing change control processes/SOPs
• Lead the design and executes the configuration of Regulatory and Quality applications
• Serves as SME and internal consultant on applications supporting Regulatory and Quality business processes and IT procedures.
• Gather specifications for system changes and new systems
• Prepare and maintain documentation relating to users, systems, programming, operations, products, services, testing and validation.
• Developing test scenarios/test cases for user acceptance testing (UAT) production validation and regression testing
• Create validation deliverables for various systems and procedures.
• Strong knowledge of the development and execution of Computer System Validation deliverables throughout the System Development Life Cycle (SDLC) such as Validation Planning, User/Functional Requirements, Design Specifications, Testing, Traceability Matrix and Final Summary Reports for industrial control systems.
• Experience with GxP validated, 21 CRF Part 11 compliant computer systems is a MUST.
• Sufficiently knowledgeable of FDA/EU Regulatory Requirements and industry best practices for computerized system validation to complete tasks.
• Working knowledge of TrackWise, Veeva Vault and ComplianceWire a plus but not required
• Ability to interact and communicate with customers in person and on teleconferences
• MUST have Pharmaceutical, Bio-Technology, or Life Science industry experience
• Technical writing ability and use of Microsoft Word, Excel, PowerPoint