How you’ll spend your day
Exposure to Laboratory Application Software in a Pharma industry and it’s validation/qualification activities as per GAMP5 guidelines
Understanding of documentation related to Quality processes such as Change Controls, CAPA, Deviations and Investigations.
Expertise in System Development Life Cycle (SDLC) structure, Computerized Systems validations and Hardware Qualifications.
Expertise in Application User Management, Back Up/Restore processes, Data Integrity Controls, Periodic Reviews, etc., as per GxP Compliance.
Knowledge of GAMP5 and regulatory guidelines such as 21 CFR Part 11, EU Annex 11, etc.
Exposure to Microsoft365 applications
Vendor Management & Collaboration
Knowledge of ERP System (preferably SAP) and first level support
Job Description Contd…
Will work as an IT Partner for the Site GM & other Site Leadership team members
Understanding the business processes with the business stakeholders and serving as IT Single Point of Contact for business applications Day-to-day Site activities associated with the IT operation of the site
Participate, represent IT in all relevant meetings and support corporate initiatives and deliverable required.
Establish and maintain effective relationships with external and internal stakeholders.
Manage Stakeholders expectations, by communicating work performed and providing a follow-up plan if needed.
Knowledge of computer maintenance and software installation & troubleshooting
Ensure regulatory and operational requirements are maintained according to Teva standards and tools (i.e; 21 CFR Part 11 etc.).
Technical Ownership of Site Application Systems
Keeping all GxP Computerized Systems in Validated State, as per Regulatory Guidelines
Act as a liaison between Site Quality Assurance, and other stakeholders to ensure compliance with applicable regulations, guidelines, and company procedures.
Act as a Stakeholder Management business analyst resource for the global labs applications installed at the site.
Enable user Access and supervise the user access management of the system to ensure that the system is accessible to authorized personnel only.
Define/supervise auto Data Backup, Restoration Process and Disaster Recovery Plan to ensure that electronic data is secured and available as and when required.
Initiating IT relevant Change Control / Deviations and Investigation & CAPA.
Handling Regulatory Inspections (FDA, MHRA, TGA, and WHO) and client audit.
Develop, implement, and maintain IT compliance policies and procedures.
Plan, execute, and manage IT projects, ensuring those are completed on time and within budget.
End User Support with regards to all Applications at site
Implement / Roll Out Global Initiatives at site, in close collaboration with Global Project/Support teams
Ensuring high levels of system and data availability
Responsible for collaboration with all regional & global business and IT groups
