, FTIR;strong cGMP/ALCOA+, FDA/ICH/USP/EP expertise. - Proven technical writing, client communication, and risk-based...
, documentation, and data integrity (ALCOA+). - Provide technical oversight for HPLC, GC, LC-MS, UV, IR, dissolution, and wet...
and reliable manufacture of products for our customers. Perform all documentation in compliance with ALCOA++ principles and site...
. Ensure compliance with GxP, 21 CFR Part 11, ALCOA+, and data integrity standards where applicable. Experience: 3...
validation aligns with Data Integrity principles (ALCOA) and includes appropriate testing strategies. Facilitate risk...
with data integrity standards (ALCOA+) and assist with change control activities (MOC, COs, etc.). Support internal...
accurate, legible, and complete records according to Current Good Manufacturing Procedures (cGMP’s) and ALCOA data integrity...
operations. Accurately complete batch records, logbooks, and other documentation in accordance with ALCOA++ principles, Good... with ALCOA++ principles and site SOPs. Adhere to applicable cGMP documents including SOPs, batch records, protocols, change...
and departmental operations Establishes data integrity governance for automated systems, ensuring ALCOA+ principles and 21 CFR Part...
. Promote Right-First-Time documentation practices and ALCOA+ data integrity principles. Monitor quality performance...