How you’ll spend your day
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, UV-Vis, GCMS 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.
Perform day-to-day system administration, maintenance & operational tasks for the Lab systems and ensures appropriate service levels are developed and monitored.
Liaison with IT operational support teams for the peripheral equipment, such as servers, desktops, printers and storage devices.
Involve in implementation of new releases, upgrades and changes in accordance with Computer Systems Validation (CSV) standards.
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.
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
Your experience and qualifications
Bachelor’s Degree preferably in Computer Science, Life Sciences, Information Systems Management, Computer Engineering, Electrical Engineering, or a related field or equivalent combination of relevant education and experience.
Experience Required:
4+ years working as a validation analyst / Data Integrity remediation activities
4+ years working in regulated pharmaceutical companies
Experience in 21 CFR Part 11, GAMP
Experience in SDLC (Agile or Waterfall)
5+ years working as a validation analyst / Data Integrity remediation activities
5+ years working in regulated (GLP, GCP or GMP) biotech or pharmaceutical companies
