-on experience and analytical problem-solving skills Proven Project Management skills and experience Experience using IQ/ OQ/ PQ...
robust process qualification/validation using IQ, OQ, and PQ methodologies. Define Receiving Inspection requirements.... Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA, and control plans. Familiarity with FDA and ISO 13485 standards. Excellent...
teams. Plans, executes, and documents testing activities including design transfer, IQ/OQ/PQ, and verification/validation...
: Execute IQ, OQ, and PQ protocols for pharmaceutical manufacturing equipment and processes. Perform hands-on test execution... industry. Hands-on experience executing IQ/OQ/PQ protocols in a GMP environment. Experience with one or more of the following...
areas for process improvement and design for manufacturability;Technical writing and validation (IQ, OQ and PQ);Mechanical...
and adhere to GMP practices, ISO 13485, and FDA regulations (e.g., 21 CFR Part 820);support validations (IQ/OQ/PQ) and audit... environment;medical device or life sciences preferred. Experience with MES validation (IQ/OQ/PQ). Minimum 2 years under GMP...
, reviewing, and executing commissioning, IQ, OQ, and PQ protocols Verification of system installation, operation, controls... execution independently Strong understanding of IQ/OQ/PQ lifecycle Excellent technical writing and documentation skills...
. Background in robotics or large capital equipment assembly. Experience with process validation planning/execution (IQ/OQ/PQ...
validations (IQ/OQ/PQ) Create PPAP documentation Other duties as assigned MPI does not discriminate on the basis of race...
expertise in CAPA management and process validations (IQ/OQ/PQ). Proven ability to oversee nonconformance handling, including...