lifecycle documentation (e.g., SRS, specifications, IQ/OQ/PQ testing, SOPs). Maintain compliance and audit readiness...
with measurable effectiveness;drive continuous improvement. Oversee instrument qualification (IQ/OQ/PQ/PM) and routine maintenance...
, and optimize cycle times. Conduct molding validations (IQ, OQ, PQ) in accordance with medical device regulatory requirements...
, including IQ/OQ/PQ Excellent problem-solving, analytical, and communication skills Ability to work cross-functionally...
on process re-qualification (IQ/OQ/PQ) Update quality documentation, inspection plans, and risk assessments during transitions...
and WFMS for PQ set up, material approvals, load scheduling, daily receipts, billing, purchase requisitions;assist...
including IQ, OQ, PQ, UAT, and system qualification. Ensure compliance with FDA, EMA, 21 CFR Part 11, GAMP 5, and Data...
best practices. Process Validation & Technical Documentation Lead and execute process validations including IQ, OQ, and PQ... processes, tooling, and materials Process validation methodologies (IQ/OQ/PQ) Statistical Process Control (SPC) and process...
, and testing plans. Execute Computer System Validation (CSV) activities including IQ, OQ, PQ, UAT, and system qualification...
engineering and validation protocols, to support process validations (IQ/OQ/PQ) and the creation of statistically derived product...