/OQ/PQ protocols and reports. Strong knowledge of 21 CFR Part 11 and EU Annex 11;ALCOA+data integrity principles...
to specify and/or purchase ALCOA ® Wheels. Additionally, this position requires extensive knowledge and thorough understanding... specification selling along with diligent follow-up after the fleet has converted to ALCOA® Wheels. Because of potential liability...
GMP documentation in compliance with ALCOA principles. Work with engineering, maintenance, and manufacturing teams...
on supervising and coordinating Performance Qualification (PQ) execution activities while ensuring compliance with GMP and ALCOA... and documentation comply with ALCOA+ principles and GMP requirements Collaborate with Validation, Quality, and Operations teams...
, biotechnology, or regulated manufacturing environments 5+ years of experience in Data Integrity/ALCOA+ principles 5+ years...
Job Description Our company is currently in search of South Ingot Area Coordinator to join our Rolled Products division in Alcoa, Tennessee...
accuracy, completeness, and compliance. Ensure all executed evidence meets data integrity (ALCOA+) and GDP standards...
packages for regulatory submissions (IND, CMC dossiers);ensure data integrity compliance (21 CFR Part 11, ALCOA+) Manage...
and ALCOA+ principles. - Deviation Identification and Investigation: Identify and escalate any atypical results and potential...
and Chapter 4), GAMP 5 and risk-based validation approaches, ALCOA+ principles and data governance frameworks Strong knowledge...