all integrations comply with GxP, 21 CFR Part 11, and ALCOA+ data integrity requirements;participate in Computer System Validation...
, documentation, validation, and change-control requirements, including ALCOA+ principles where applicable. Other Duties As Assigned... control, GMP or ISO quality systems, cybersecurity, and ALCOA+ data-integrity expectations. Experience integrating...
brochures, DSURs, IMPD, marketing applications, and health authority responses, as assigned Perform independent ALCOA+ checks...
Shape Your World At Alcoa, you will become an essential part of our purpose: to turn raw potential into real progress... through technology. In this role, you will help define and advance Alcoa’s Finance technology portfolio, connecting Finance...
quality requirements. Ensure activities comply with GxP, ALCOA+ data-integrity principles, regulatory requirements... of GxP, ALCOA+ data-integrity principles, ICH Q2, ICH Q10, ICH Q14, and relevant FDA, EMA, and other regulatory expectations...
with DOE and tools such as JMP. Verify data (ALCOA+). Deviation and risk management: Lead or technically support FMEA...
, GAMP 5, 21 CFR Part 11, ALCOA+, internal procedures, and other regulatory requirements. This position establishes... Part 11 ALCOA+ Risk-based validation methodologies Strong understanding of SDLC and Agile development methodologies...
adherence to ALCOA+ principles and 21 CFR Part 11 requirements. Balance quality and compliance needs with safety requirements...
integrity principles (ALCOA+), and applicable regulatory expectations. Experience supporting manufacturing investigations...
Documentation Practices (GDP), ensuring adherence to ALCOA+ principles across the document lifecycle. The role partners closely... adherence to Good Documentation Practices (GDP) and ALCOA+ principles across all GMP documentation. Controlled Documents...