System Analyst 6
with vendors and IT teams on system upgrades, integrations, and issue resolution Assist in validation activities (IQ/OQ/PQ...
with vendors and IT teams on system upgrades, integrations, and issue resolution Assist in validation activities (IQ/OQ/PQ...
Validation Utilities Validation (PW, WFI, HVAC, Compressed Air) Equipment Qualification (IQ/OQ/PQ) CSV (GAMP 5, 21 CFR Part 11...
on packaging lines. Execute equipment qualification (IQ/OQ/PQ) for serialization components. Collaborate with automation and IT...
instrument qualification documents including but not limited to: IQ, OQ and PQ Protocols Maintain calibration and preventative...
(one of) CDI, Q, PQ or RI stamps . Support inventory accuracy goals through regular and accurate cycle counting . Support...
, URS, Software Acceptance Testing (SAT) IQ, OQ, PQ and cleaning phases. Responsible for the following ongoing validation...
in: Fixture design and development Test method validation Equipment validation (IQ, OQ, PQ) Proficiency in statistical analysis...
standards (e.g., FDA, ISO, CE). Perform validation protocols (IQ, OQ, PQ) and ensure that validation documentation is complete...
and residues Define worst-case equipment trains/circuits and justification approach Develop and support PQ strategy for cleaning...-case determination Cleaning validation PQ strategy development Risk-based validation approaches leveraging existing data...
, and validation lifecycle (IQ/OQ/PQ) Excellent documentation and communication skills Ability to provide manager/supervisor...