Shape Your World At Alcoa, you will become an essential part of our purpose: to turn raw potential into real progress.... The way we see it, every Alcoan is a work-shaper, team-shaper, idea-shaper & world-shaper. Alcoa Massena Operations...
, Q9, Q10 Auditing Root cause methodologies/CAPA Data Integrity (ALCOA+) Cleanroom classifications (ISO 14644...
with applicable SOPs, methods/protocols, good documentation practices, data integrity standards (ALCOA+), cGMPs, EHS requirements... documentation practices (GDP) and data integrity principles (ALCOA+). Proven ability to communicate and collaborate effectively...
with cGMP, data integrity (ALCOA+), cybersecurity, and company automation standards through collaboration with system owners...
Systems planning Knowledge of cGMP, GAMP, 21 CFR Part 11, and Annex 11;strong understanding of ALCOA+ principles and data...
comply with GxP, FDA 21 CFR Part 11, ALCOA+, and global regulatory requirements. Establish documentation standards, SOPs...
analysis, machine learning, or comparable tools. Working knowledge of GMP, ALCOA+, 21 CFR Part 11, ICH guidance, regulated...
(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...
methods;ensure ALCOA+ data integrity. Document and investigate out-of-specification (OOS) and out-of-trend (OOT) results...
(ALCOA+), cGMPs, EHS requirements, chemical hygiene, and biosafety guidelines, maintaining an ongoing state of inspection.... Proficient in good documentation practices (GDP) and data integrity principles (ALCOA+). Proven ability to communicate...