scale-up, facility readiness, equipment installation, qualification (IQ/OQ/PQ), and operational handoff. Ensure new...
process qualification/validation using IQ, OQ, and PQ methodologies. Inspection & Test Method Validation: Define.../PQ, PFMEA, MSA, and control plans. Familiarity with FDA and ISO 13485 standards. Excellent communication and problem...
. Participate in improvement initiatives . Ability to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps...
on requirements. Support process development and validation activities, including IQ/OQ/PQ protocols for medical device and related...
of materials required for analytical testing · Assist with analytical equipment IQ/OQ/PQ protocol execution · Coordinate...
, execution support, and record maintenance. Support IQ/OQ/PQ testing activities under direction of senior validation staff...
equipment requirements, support vendor evaluations, lead installations, and oversee equipment validation (IQ/OQ/PQ.... Generate and execute process validation protocols (IQ/OQ/PQ, PPQ) in alignment with medical device regulatory expectations...
Key Responsibilities: Writing and execution of validation protocols and reports (i.E. IQ, OQ, PQ, etc.) Developing...
knowledge of machines throughout the conversion area. You will be responsible for completing the required training measures (PQ...
, and PQ processes Provide statistical support to analyze manufacturing processes and to recommend appropriate process...