Integrity (DI) principles (ALCOA+ preferred). Experience in Manufacturing (Filling/Packaging/Production) OR QC Laboratory...
dashboards and service reviews. Ensure compliance with GxP/data?integrity expectations (e.g., GAMP 5, ALCOA+), and support audits...
and service reviews. Ensure compliance with GxP/dataintegrity expectations (e.g., GAMP 5, ALCOA+), and support audits, CAPAs...
, ALCOA+), and support audits, CAPAs, deviations, and change control for computerized systems. Coordinate site readiness...
, test summaries) in alignment with ALCOA+ and Good Documentation Practices Assess AI/ML solutions and analytics platforms...., FDA, EMA, ICH), data integrity requirements, and ALCOA+ principles Familiarity with AI, Machine Learning, advanced...
steps following ALCOA and GMP processes as needed. Maintain audit ready production area and adhere to all regulations...
(e.g., GMARS), or similar work order tracking system Document work using good documentation practices (ALCOA...
ALCOA+ principles Maintain high standards of safety, cleanliness, PPE usage, and 5S practices Communicate effectively...
all procedures and results in approved systems (e-source, logs, etc.) according to ALCOA-C++ and ensure regulatory compliance (GxP...
, ALCOA+, USDA, and AAALAC guidelines, and can identify areas for improvement. Additional Skills & Qualifications Bachelor...