Teva Business Process Analyst II 

India, Maharashtra, Navi Mumbai 

146843951

Support implementation of new solutions, testing, management, troubleshooting, and administration of new and existing systems within Generics and Specialty areas of a Pharmaceutical laboratory environment which include but not limited to Chromatography Data Systems such as Empower, MassHunter, Unifi (Q-TOF), Sciex Analyst, etc.
Support delivery of IT services and coordination with local, regional and global resources on the status of projects, service and support efforts.
Collaborate with laboratory business, staff, IT colleagues, and other stakeholders to support existing processes and technologies. Identify customer requirements; assess impacts to the delivery of applications and other IT functions.
Involved in implementation of new releases, upgrades and changes in accordance with Computer Systems Validation (CSV) standards.
Perform day-to-day system administration, maintenance & operational tasks for the Lab systems and ensures appropriate service levels are developed and monitored.
Perform PC/System specification configuration according to vendor requirements, works with IT Operations (ITO) for PC lab build, user group assignment and management, data backup setup and control, test data backup and restore, IQ/OQ test execution and documentation.Support with tasks and deliverables related to Software Development Life Cycle (SDLC) phases for laboratory computer systems. Ensures that system implementations are in keeping with the relevant FDA 21 CFR Part 11, GxP guidelines as well as internal policies and processes.
Ensure compliance with Data Integrity requirements and remediation activities for Laboratory systems.

Degree qualified - preferably in Computer Science, Information Systems Management, Computer Engineering, Electrical Engineering, Life Sciences or a related field

Key Skills and Experience
Experience working in a highly regulated environment within the pharmaceutical laboratory environment
Knowledge and experience of cGMP and its implementation to laboratory instrumentation and laboratory processes
Experience in providing face-to-face and remote end user support to laboratory users and applications in a highly regulated environment within the Pharmaceutical Industry.
Excellent verbal and written English communication skills.

Associate Director IT Business Application

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