Teva Business Process Analyst III 

India, Tamil Nadu, Chennai 

13106411

• 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

• 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

• B.Sc. Computer Science / BCA / PGDCA / B.Tech. / B.E. (Computer Science/IT) Degree/Diploma in Management (Desirable)
• 6-10 Years

Associate Director IT