Report this job

---

What is the problem? *

Incorrect company
Incorrect location
Job is expired
Job may be a scam
Other

Responsibilities:

• Developing and executing CSV/AIQ deliverables according to regulatory authorities for GxP computer systems to support commercial and development activities.
• IT Experience deploying and supporting Quality Systems including Analytical Instruments - Empower, Chromeleon, SOLO VPE, Roche Cedex, Roche LightCycler 480, GE DataPro2, Lonza WinKQCL,
• Mettler Toledo Lab)(, Thermo WebAdmin for TruScan RM Analyzer, and vartous Laboratory desktop applications used in GxP environment
• Experience working with ITIL processes in ServiceNow such as Incident Managemen Change
• Management, Problem Management, Asset and Gonfiauratlon Manaaement (GMDB)
• Setup of computers using supplied (computer & OS) computer and image. Confirm/Install applicable enterprise applications for corporate standard anti-virus and related tools.
• Author and revise system design and configuration specification documents for new and ongoing projects. Also author the validation documents include incorporating holistic data integrity
• methodologies, backup/restore testing, disaster'recovery planning and related activities.
• Periodic review of QC lab Systems (Document review. backup & restore verification, audit trail review user account review).
• Assess pre-existing GxP computer systems for compliance gaps and recommend solutions
• Participate in cross-functional Project teams to ensure business needs are met and implemented in compliance with associated predicate rules and governing regulations.
• Pro-actively monitors systems and processes to ensure compliance with standard operating procedures audit compliance and industry best practices.
• Technical approver for project-related CSV/AIQ documents on cross-functional teams that include Business Owners. IT CSV project engineer's IT System Administrators and System Owners and Quality Assurance on projects including clinical data repositories master data management
• systems, laboratory systems and other systems supporting clinical manufacturing or quality processes.
• Act as business administrator for automated systems, software application, including managing accounts change/patch management, and any associated maintenance.
• Can easily decipher from a lab system where data objects are stored and how its protected (main data, audit trail, methods, reports, templates, etc.). As a result, being able to develop data flow diagrams that also tie to how a system will be used.
• Work with infrastructure teams to assure proper backups of Lab systems are setup.
• Use various IT tools such as windows NTFS permissions, active directory, group policies, etc. to implement and deploy systems with data integrity risks minimized.
• Deploy workstations and install applications on both client and servers as needed for application.
• Support ongoing DI related initiatives, Remediation Plans and other projects.
• Perform and help with periodic activities like User account reviews, Audit trail reviews and Admin audit Iran reviews as system owner
• Follow Computerized Systems Validation (CSV) process and Software Development LifeCycle (SDLC) methodology to build out and qualify the application.
• As application SME, work with infrastructure teams to request server architecture, and perform installation of application.
• Directly responsible for deployment, as well a authoring IT validation documents such as System Design and Configuration Specifications (SDCS's) and Installation Qualifications (IQ), Backup Configuration and Restore Protocols, and System Administration Procedures.
• Assist with and provide input as SME and System Owner for other documents in validation process, such as User and/or Functional Requirements, Risk Assessments, Operational Qualification related to software functions, etc.
• As incidents come in, work on troubleshooting and resolving issues for end users for site applications.
• Contacting vendors as needed for troubleshooting and resolving issues.
• Creation/Modification of user accounts in applications as needed following administration procedures