Installation -Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Develop and maintain project...
, overseeing Computer System Validation (CSV) activities, including URS, FS, RA, IQ, OQ, PQ, and validation reports. Collaborate...
to ensure compliance with EU GMP, FDA, HPRA, and SGS requirements Manage the installation, qualification (IQ/OQ/PQ...
requirements Ensure maintenance activities comply with the site Quality Management System Support FAT, SAT, IQ, OQ, and PQ...
/OQ/PQ phase. Data collection, analyzing and reporting of all NPI activity including standard template to document... (IQ, OQ & PQ). Effective step by step release and Quality checks of all New Product introduction phases covering risks...
deliverables, including: protocols, reports, specifications, manuals, work instructions, procedures, qualifications (IQ, OQ, PQ..., including IQ/OQ/PQ protocols, engineering studies, work instructions, and technical reports. Initiate and support intra...
and executing validation protocols (IQ/OQ/PQ), preparing final validation packages, and supporting FUE qualification, CSV, New...
and support CSV documentation such as Validation Plans, URS, Risk Assessments, IQ, OQ, PQ, and final reports. Apply risk-based...
, and standard operating procedures (SOPs) Lead and execute process validation activities (IQ/OQ/PQ) Ensure compliance with FDA... validation and documentation Knowledge of FDA QSR, ISO 13485, GMP Experience with IQ/OQ/PQ validation INDTRAC...
protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ...