At AM INSTRUMENTS, I write and review Master Batch Records, SOPs, and work instructions in line with EU GMP, keeping documentation audit-ready. I manage the document lifecycle in Gamma Enterprise, reducing generation and completion time by over 30%.
I also coordinated and trained a team of 20 production operators, and worked with QA and Project Management to align documentation with production schedules.
Previously at RECIPHARM BIL, I supported sterile liquid ampoule production, coordinated 30 operators, and worked with QA on nonconformities and CAPA. I also reviewed batch records on Adiuto and used SAP for document management and production monitoring.
