frameworks: GxP, 21 CFR Part 11, GDPR, ALCOA+, computer system validation (CSV), and audit readiness. Proven ability to manage...
, revise, and complete documentation in accordance with cGMP and ALCOA principles. Ensure equipment and building monitoring...
, revise, and complete documentation in accordance with cGMP and ALCOA principles. Ensure equipment and building monitoring...
in a regulated environment (ALCOA principles). Experience developing and validating bioanalytical methods for small molecules, large...
in a regulated environment (ALCOA principles). Experience developing and validating bioanalytical methods for small molecules, large...
in protocol interpretation, data collection strategies, and data cleaning specification development. Knowledge of ALCOA++ data...
. Ensure data integrity (ALCOA+) and compliance with GMP/GLP standards. Provide technical consulting, troubleshooting...
documentation per ALCOA+ guidelines Develop trend analysis reports and maintain comprehensive infrastructure and compliance...
in compliance with ALCOA+ Experience working with GxP regulations and 21 CFR Part 11 Experience mentoring and coaching teams...
Assurance (CSA) fundamental concepts. Basic understanding of data integrity (ALCOA+) principles. Strong customer service skills...