Supervisor, Drug Product Formulation & Autoclave
Acceptance Testing (SAT), Operational Qualification (OQ), and Performance Qualification (PQ), travel as needed Manages...
Acceptance Testing (SAT), Operational Qualification (OQ), and Performance Qualification (PQ), travel as needed Manages...
preventive and unscheduled maintenance activities on their equipment within their assigned work center. Support IQ, OQ, and PQ...
for AI-driven decision-making systems. Author and review validation documentation (URS, FS, DS, IQ/OQ/PQ protocols, reports...
with PowerShell scripting for automation and validation tasks. ⦠Experience in software validation methodologies, including IQ/OQ/PQ...
results from 1st article and Process validations (IQ-OQ-PQ) studies during product launch and subsequent changes to tooling... process, such as process improvement, problem-solving, AQL Levels, FMEA, validations (IQ/OQ/PQ), DOE, and metrics. Provide...
customers. You’ll lead continuous improvement efforts, develop and validate robust manufacturing processes (IQ, OQ, PQ, gauge... or updated assembly procedures to ensure smooth production readiness. Lead process validation activities, including IQ, OQ, PQ, gauge R&R...
, and IQ/OQ/PQ. Monitor yields, troubleshoot production issues, and drive corrective actions. Conduct performance reviews...-on experience with validation (IQ/OQ/PQ) and process documentation. Knowledge of FDA 21 CFR 820, ISO 13485, and international...
qualification (IQ, OQ, PQ). Develop, review, and execute validation protocols and reports in compliance with GMP standards...
integrations, and equipment validation. Familiarity with process utilities and equipment qualification protocols (IQ/OQ/PQ...
: Ensure IQ/OQ/PQ, calibration, traceability, and compliance with GMP/ISO standards in a regulated MedTech environment. Aim... (Operational Qualification), and PQ (Performance Qualification) protocols and reports. Proficiency in developing and executing IQ...