for supplier interactions and work you're doing. Assess risk through FMEAs and develop process validation plans (MVP, IQ/OQ/PQ...
of experiments (DOE), process validation (IQ/OQ/PQ), and test method validation (TMV) protocols and reports. Drive continuous... process development and validation activities (IQ/OQ/PQ), DOE, and process characterization. Consistent record driving Lean...
regulations. Experience and understanding Process Validations (IQ, OQ, PQ), 6S, Lean Manufacturing Experience applying...
, validations (IQ/OQ/PQ), and change control. Provide hands-on support for line issues, root‑cause investigations, and CAPA...
Admin SOPs, Risk Assessments, User Requirements (URS), Test Protocols (IQ/OQ/PQ), etc. Create change controls, periodic...
, IQ, OQ, and PQ. Coordinate with internal stakeholders (production, maintenance, quality, R&D) for seamless handover.... Manage unloading, installation, commissioning, and validation of electrical equipment. Support PQ execution and final...
, IQ/OQ/PQ protocols). Oversee lifecycle management of automated systems, ensuring adherence to 21 CFR Part 11, FDA, EU...
in a regulated medical-device environment. Create URS and FMEA documentation, execute risk-based IQ/OQ/PQ/SQ, support CAPA/NCRs...: Develop URS, conduct risk assessments, plan/execute IQ/OQ/PQ/SQ, manage deviations, and produce audit-ready reports. CAPA...
, develop and implement engineering studies and IQ/OQ/PQ/TMV validations for equipment and processes to meet the demands of new...
, GMP, ISO 13485, etc). Initiate, develop and implement engineering studies and IQ/OQ/PQ/TMV validations for equipment...