Validation of software applicationsmodules and associated interfaces and generating deliverables according to business needs and internal procedures.
Ensures compliance with Data Integrity requirements and remediation activities for Laboratory systems.
Ensures IT solutions are compliant with the appropriate regulations and TEVA standards governing computer systems through the entire lifecycle.
Authors, reviews, approves, executes (as applicable) computer system validation documents - Computer System Risk Assessments, Validation Plans & Reports, User requirements, Functional & Design specifications, Qualification ProtocolsTest Scripts (IQ, OQ, PQ, UAT), Trace Matrix etc.
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.
5+ years working as a validation analyst Data Integrity remediation activities
5+ years working in regulated (GLP, GCP or GMP) biotech or pharmaceutical companies
Experience in 21 CFR Part 11, GAMP
Experience in SDLC (Agile or Waterfall)
Ability to interface directly with various Business, QA and IT functional areas. Remotely support other Teva sites across multiple zones as needed in a highly regulated environment within the Pharmaceutical Industry.
Keyskills: Computer science remediation Test scripts Agile Business process analysis Life sciences data integrity GMP Information technology SDLC
Watson Pharmaceuticals, Inc. (NYSE-WPI) is a global specialty pharmaceutical company with approximately $3 billion in revenues, a broad product line and operations in well-established and emerging markets.