and maintain data validation plans, including programmatic and manual edit checks to support ALCOA+ data quality principles Lead...
and organized manner following ALCOA principles. In addition to analytical capabilities, the incumbent should have knowledge...
in a detailed and organized manner following SOPs and ALCOA principles. Troubleshoot and investigate any challenges associated...
requirements, data integrity principles (ALCOA+), and validated SDLC practices Excellent communication skills, demonstrated...
— apply ALCOA+ principles and data lifecycle controls across all governed systems. Support audit and inspection readiness — lead...
- apply ALCOA+ principles and data lifecycle controls across all governed systems. Support audit and inspection readiness - lead...
with cGMP, data integrity (ALCOA+), cybersecurity, and company automation standards through collaboration with system owners...
industries strongly preferred. Understanding of GxP, SOX, audit, CSV, data integrity (ALCOA+), GDPR, and quality requirements...
Systems planning Knowledge of cGMP, GAMP, 21 CFR Part 11, and Annex 11;strong understanding of ALCOA+ principles and data...
(ALCOA+), storage, retention, and integrity monitoring for regulated laboratory and manufacturing data Coordinate periodic... as assigned Key Skills Strong understanding of GLP/GMP expectations for computerized systems, including 21 CFR Part 11, ALCOA...