and maintain data validation plans, including programmatic and manual edit checks to support ALCOA+ data quality principles Lead...
and archival align with regulatory and company requirements. Champion data integrity (ALCOA+) and compliance with 21 CFR Part 11...
Integrity/ALCOA+). Advise and guide onsite/remote validation consultants on qualification strategy, deviations, test design.... CSV/CSA: 21 CFR Part 11, EU Annex 11, GAMP 5 (2nd Edition), Data Integrity (ALCOA+), risk-based testing, supplier...
methods;ensure ALCOA+ data integrity. Document and investigate out-of-specification (OOS) and out-of-trend (OOT) results...
Strong understanding of ALCOA+ principles, data integrity requirements, and data governance practices Proficiency in risk assessment...
Shape Your World At Alcoa, you will become an essential part of our purpose: to turn raw potential into real progress...: We are seeking a talented HR Business Partner to join our team at Alcoa in Massena, NY. In this dynamic role, you’ll be supporting...
requirements. Design and implement automation systems in compliance with ALCOA data integrity principles (Attributable, Legible...
Part 11, EU Annex 11, ALCOA++ Principles, etc. Experience in leading CSV activities across the full system lifecycle...
execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA principles...
environment strongly preferred — familiarity with GMP, 21 CFR Part 11, ALCOA+, and CSA/CSV practices. Experience working...