closely with Engineering, Quality Assurance, and Operations to ensure that all validation activities meet regulatory.... What you will do · Review and approve validation protocols (IQ/OQ/PQ) for equipment, manufacturing processes, and cleaning procedures. Develop...
and executes the coordination of project activities with affected departments including Manufacturing, Quality Assurance... and preparation of required cGMP documentation for complex pharmaceutical systems, including IQ/OQ/PQ protocols. Observes safe...
, including Validation Plans, IQ/OQ/PQs, and Validation Summary Reports. Regulatory Compliance: Enforce rigorous regulatory... in Software Quality Assurance or Compliance within a regulated industry (Diagnostics, MedTech, Pharma, or Biotech preferred). CSV...
with measurable effectiveness;drive continuous improvement. Oversee instrument qualification (IQ/OQ/PQ/PM) and routine maintenance... initiatives to increase laboratory efficiency and analytical capability. Collaborate cross-functionally with Quality Assurance...
FactoryTalk PharmaSuite and related manufacturing systems. Collaborate with IT/OT, Quality Assurance, Manufacturing, System... including IQ, OQ, PQ, UAT, and system qualification. Ensure compliance with FDA, EMA, 21 CFR Part 11, GAMP 5, and Data...
with Engineering, Quality Assurance, and Operations to ensure validation and hygiene programs meet regulatory and internal requirements..., and facility changes, including development, standardization, and approval of IQ/OQ/PQ protocols and final reports. Define...
and/or manufacturing experience, including technical operations, technical transfer, or technical assurance positions preferred Additional... experience and familiarity with IQ/OQ/PQ, method development and validation, and PV processes and requirements preferred...
that help drive product development, quality assurance, and consumer insights. You will prepare and conduct sensory testing... social media and survey programs. Upload reports to the shared drive and/or Perdue iQ research library. Communicate...
between Research & Development, Quality Control, and Quality Assurance. The position has direct influence on biological risk assessment... validation activities, aligned with IQ/OP/PQ principes where applicable Author validation protocols, risk assessments and final...
maintenance, HVAC/cleanroom systems, and critical utilities to meet GMP expectations. Improve sterility assurance practices..., including HEPA filtration, environmental monitoring, and utility performance. Enhance equipment qualification (IQ/OQ/PQ...