Job Description Job Description
Key Responsibilities:- GMP / GxP Operations: Support Quality Control IT operations, computer system validation (CSV) periodic reviews (backup/restore testing, user access, audit trails), and GxP workstation patching.
- Front-Line Support & Decommissioning: Provide triage for system downtime, coordinate vendor repairs, handle Windows 7 to 10 upgrades, and perform system decommissioning (account deactivations, final backups).
- Documentation & Testing: Author and execute SDLC validation artifacts (URS, FRA, IQ, IOQ, ATR, Admin SOPs, Data Flow diagrams) adhering to 21 CFR Part 11 and Data Integrity compliance.
- Lab Instrument Support: Provide technical oversight and application support for lab equipment (e.g., Vaya Raman, 7500 Fast PCR, Hiac Particle Counters, Maldi-TOF, Vi-Cell, Antaris II, Waters Alliance).
Education and Experience:- Experience: 5 years of IT/Business Analysis experience supporting software implementations in GxP/Pharmaceutical environments.
- Key Tools & Systems: ServiceNow (Incident/Change/Problem), TrackWise (CAPA, Deviations), Veeva, Active Directory, MyAccess, and NTFS permissions.
- Lab Software Knowledge: Empower, Chromeleon, LabX, WinKQCL, or related GxP laboratory desktop software.
- Education: Bachelor's degree in IT, CS, Engineering, or Business Administration (or equivalent).