How you’ll spend your day
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.
Handle vendor resources at site and provide day-day assistance to them.
Ensuring vendor availability and support during the project implementation phase
Arranging and documenting multiple training sessions for all stakeholders.
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 customers ensuring their success.
Manage customer 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.).
Act as a liaison between Site Quality Assurance, and other stakeholders to ensure compliance with applicable regulations, guidelines, and company procedures.
Your experience and qualifications
Bachelor’s degree
4-7 years relevant experience working as an application engineer
Experience in IT handling IT applications
Experience/Training in testing methodologies and validation procedures
Work effectively in a multi-task environment
Interpersonal and communications skills
Working with GxP systems – Advantage.
Experience in pharmaceutical industry and clinical studies – Advantage
English fluent – verbal and writing
Understanding compliance
