improvements. Working knowledge of GMP, ALCOA+, 21 CFR Part 11 expectations, ICH guidance, regulated documentation, change control...
Quality (DQ) or comparable DQ tooling Experience in a regulated industry with DQ experience (ALCOA+, Part 11) Experience...
11, EU Annex 11, and ALCOA+ data integrity principles. Experience supporting Change Control, CAPA, deviation...
- apply ALCOA+ principles and data lifecycle controls across all governed systems. Support audit and inspection readiness - lead...
, and data integrity (ALCOA+). Directs impact assessment and requirements definition for integrations between quality systems... validation, and data integrity (ALCOA+) requirements as they apply to requirements and design documentation. Proven...
computer system validation, change control, and documentation obligations under GxP, 21 CFR Part 11, and data integrity (ALCOA... working knowledge of GxP, 21 CFR Part 11, computer system validation, and data integrity (ALCOA+) requirements...
practices. Document work accurately and contemporaneously in compliance with cGMP and data integrity (ALCOA+) expectations...
(ALCOA+) expectations. Collaborate with cleaning validation, Manufacturing, Quality, and Process Development partners...
ALCOA+ integrity, retention, lineage, and consent contracts, that stand as software/data design inputs under 21 CFR 820.30(c... or clinical data, ALCOA+ integrity, and data governance (access, consent, retention). Familiarity with feature stores, semantic...
/CSV, ALCOA+, audit trails, electronic records, requirements/test traceability and validated-state change control...