Senior Compliance Manager, US
-mile / intended-use validation of a commercial SaaS or cloud product — including IQ/OQ/PQ scoping, validation plan...
-mile / intended-use validation of a commercial SaaS or cloud product — including IQ/OQ/PQ scoping, validation plan...
Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Participate in regulatory inspections...
Responsibilities: Lead equipment qualification activities including IQ, OQ, and PQ Support full process validation lifecycle... from process characterization through PQ Design and improve manufacturing processes, production layouts, and system integrations...
Management & Validation Validation & Commissioning: Mastery of the V-Model approach, including IQ/OQ/PQ protocols and Turnover...
(IQ/OQ/PQ) for a medical device production facility. The role involves ensuring that manufacturing systems, equipment... (PQ) activities for manufacturing equipment and processes Develop, review, and execute validation protocols and reports...
and execute process validation (IQ, OQ, PQ), risk assessments (per ISO 13485), and process control strategies to support robust...
activities. Plan and execute process validation activities (IQ/OQ/PQ) in compliance with FDA QSR, ISO 13485, and applicable..., Chemical or related field) required;Advanced degree preferred. Must have strong knowledge in: Process validation (IQ/OQ/PQ...
experiments. Solve formulation and process problems. Author SOP’s, IQ/OQ/PQ documents, development and technical reports...
and corrective actions Support new and transferred projects using APQP, PPAP and IQ/OQ/PQ methodologies Lead, develop and mentor..., PFMEA and qualification processes (IQ/OQ/PQ) Familiarity with Lean Manufacturing and supplier quality improvement...
/PQ scoping, validation plan authoring, risk assessment, and CSA-aligned testing. Demonstrated ability to operate...