: Apply GAMP5/CSA, CSV deliverables (URS, risk, testing, traceability), and ALCOA+ data integrity;support audits/inspections...
, data integrity (ALCOA+), and 21 CFR Part 11 / EMA Annex 11 expectations;escalate compliance concerns to Quality. Support... and validation deliverables Familiarity with GMP, 21 CFR Part 11, ALCOA+ data integrity principles, and validation practices...
regulatory audits Data Integrity & Risk Management * Apply ALCOA+ principles (Attributable, Legible, Contemporaneous, Original...
. Efficient organizational and planning skills. Attention to detail and commitment to data integrity (ALCOA principles...
, federal/state regulations, internal standards, and ALCOA+ data integrity principles Oversee testing of raw materials... control, and data integrity (ALCOA+) Familiarity with ERP systems (e.g., Chempax, Oracle, or similar) Core Competencies...
integrity assessments (ALCOA+), access reviews, and cybersecurity controls evidence. Support internal/external audits (QA...
, including 21 CFR Part 11, Annex 11, and data integrity principles (ALCOA++). Experience with computerized system validation...
(ALCOA+). Learn, follow, and maintain compliance with SOPs, safety policies, and PPE requirements. Demonstrate consistent...
our clinical partner. Perform Data Management tasks: Following ALCOA-C guidelines, all data collected must be attributable...
Accountant to join our Rolled Products North America (RPNA) business unit in Alcoa, TN. Arconic's Tennessee Operations...