or Six Sigma certification preferred Strong knowledge of IQ/OQ/PQ requirements, measurement system analysis, and supporting...
process validation and equipment qualification activities, including IQ/OQ/PQ protocols. This role ensures... concepts to diverse audiences and stakeholders Process Validation Expertise – Deep experience in IQ/OQ/TMV/PQ/, process...
of process validation strategies, including IQ/OQ/PQ activities and validation documentation. Lead risk management activities...
: equipment and automation, process validation (IQ/OQ/PQ), DOE, PFMEA, and lean manufacturing Knowledge of QSR and ISO...
, URSs, FATs, SATs, DQ, IQ, OQ, PQ and other relevant validation life cycle documents Develop/Author validation master plans...
improvements. Write and execute Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ... with CAD software (SolidWorks preferred) for tooling, fixture, and equipment design Experience writing and executing IQ/OQ/PQ...
, you will be responsible for… Lead end-to-end validation activities for GxP systems, including validation plans, IQ/OQ/PQ protocols, summary... for GxP systems, including IQ/OQ/PQ protocols, validation plans, summary reports, user requirements specifications, functional...
and approval of process and equipment validation/qualifications (IQ, OQ, PQ) Lead and/or support CAPA investigations and related...
environments Cleanroom construction and classified spaces Brownfield capital projects Commissioning & Startup IQ/OQ/PQ support...
), and Performance Qualification (PQ) for equipment, utilities, and manufacturing processes used in OTC Drug production - Familiarity... for complementary medicines - Experience reviewing or auditing IQ/OQ/PQ validation protocols and summary reports for manufacturing...