, quality engineering outcomes, and compliance. Coordinate and support equipment validation activities, including IQ, OQ, PQ..., validation protocols, IQ, OQ, PQ, process validation, and equipment validation in a regulated setting. Demonstrated capability...
) Performance Qualification (PQ) Traceability Matrices Validation Summary Reports (VSR) Ensure compliance with: FDA 21 CFR Part...
approaches (IQ/OQ/DQ/PQ). Provide production line support for day-to-day engineering issues Identify and implement continuous...
Qualification), OQ (Operational Qualification) and PQ (Performance Qualification). Independently write and review qualification...
, scripts, and traceability documentation. Participate in validation phases (IQ/OQ/PQ/UAT) and ensure adherence to quality...
documentation for equipment DQ, IQ, OQ, PQ validations. Conduct effective design reviews of new equipment at all stages...
within a medical device or manufacturing environment Experience with root cause analysis and process validation (IQ, OQ, PQ) Strong...
teams in the production environment along with using troubleshooting techniques to solve PQ related issues. KEY DUTIES...
validation activities during DQ, FAT, IQ, OQ, SAT and PQ phases. Establish, manage, and maintain automation project budgets...
and/or support IQ, OQ, PQ activities. Quality Systems & Compliance Develop, maintain, and approve SOPs, work instructions...