Project Engineer
and preparation of required cGMP documentation for complex pharmaceutical systems, including IQ/OQ/PQ protocols. Observes safe...
and preparation of required cGMP documentation for complex pharmaceutical systems, including IQ/OQ/PQ protocols. Observes safe...
, including IQ/OQ/PQ Excellent problem-solving, analytical, and communication skills Ability to work cross-functionally...
with measurable effectiveness;drive continuous improvement. Oversee instrument qualification (IQ/OQ/PQ/PM) and routine maintenance...
using data analysis and Six Sigma methodologies. Coordinate installation, validation (IQ/OQ/PQ), and optimisation of new...
on process re-qualification (IQ/OQ/PQ) Update quality documentation, inspection plans, and risk assessments during transitions...
Computer System Validation (CSV) and authoring validation documentation (e.g., URS, IQ/OQ/PQ, traceability). Solid...
appropriate documentation. IQ/QQ/PQ validation, statistical process capability (CP/CPK), cavity pressure-driven process control...
using data analysis and Six Sigma methodologies. Coordinate installation, validation (IQ/OQ/PQ), and optimisation of new...
lifecycle documentation (e.g., SRS, specifications, IQ/OQ/PQ testing, SOPs). Maintain compliance and audit readiness...
including IQ, OQ, PQ, UAT, and system qualification. Ensure compliance with FDA, EMA, 21 CFR Part 11, GAMP 5, and Data...