& Compliance: Lead the execution of Equipment Installation Qualifications (IQ) and Process Validations (OQ/PQ) to ensure...
. Responsibilities Lead and execute installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ.../OQ/PQ execution and documentation for laboratory instruments and utilities. Installation Qualification experience...
activities. Participate in IQ/OQ/PQ validation activities, including drafting, reviewing, and executing protocols...
development. Additionally, it involves funds approval, detailed design, development and fabrication, IQ/OQ/PQ (installation...
lesson plans). Professional Development Maintaining an accurate and up to date PQ registry Maintaining the required 20...
Development Maintaining an accurate and up to date PQ registry Maintaining the required 20 hours of professional Development...
). Participate in or support PQ (Performance Qualification) testing and related quality activities, as applicable. Communicate.... Experience with PQ (Performance Qualification) testing in a GMP setting. Familiarity with FDA expectations for advanced therapy...
operations. Key Responsibilities Execute IQ, OQ, and PQ activities for GMP equipment and systems. Prepare and review...
and regulatory compliance with 21 CFR Parts 210/211, 820, ISO 13485, USP and ICH guidelines. Support product validation (IQ/OQ/PQ...
, UAT, PQ, and performance testing. Manage release-level deployment risks, issues, dependencies, and escalations...