Validation Lead
, cleaning validation, and utility validation. Good understanding of cGMP, FDA guidelines, 21 CFR Part 11, GAMP 5, ALCOA...
, cleaning validation, and utility validation. Good understanding of cGMP, FDA guidelines, 21 CFR Part 11, GAMP 5, ALCOA...
(ALCOA) Experience in Lean lab practices Effective troubleshooting and problem-solving skills Ability to work...
with ALCOA+ data integrity standards Supplemental Functions: · Assists in programming Blue Mountain RAM by writing...
audits, and regulatory inspections. Ensure compliance with 21 CFR Part 210/211, ICH guidelines, GDP, and ALCOA+ data...
handling, and integration monitoring in GMP environments. GxP/CSV: GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+, IQ/OQ/PQ... all MES and integration deliverables comply with GMP, GxP, 21 CFR Part 11, GAMP 5, and ALCOA+ requirements throughout the program lifecycle....
readiness in compliance with cGMP, data integrity (ALCOA+), and regulatory requirements. Responsibilities Perform... schedules. Execute laboratory operations in compliance with cGMP, data integrity (ALCOA+) principles, applicable regulatory...
initiatives, ensuring adherence to ALCOA+ principles Manage and support change control processes, ensuring impact assessments...
integrity and systems (ALCOA principles: attributable, legible, contemporaneous, original, accurate) Maintain/oversee LIMS...
. Strong understanding of Data Integrity principles (ALCOA+), Computerized System Validation (CSV), and Change Control & CAPA processes...
, 210, 211, Annex 11, and applicable global regulations. Establish and maintain Data Integrity governance, ensuring ALCOA...