, configuration workbooks, data migration plans, and GxP validation artefacts including IQ/OQ/PQ test scripts and traceability... activities including IQ/OQ/PQ execution, traceability matrix development, and preparation of GxP-compliant documentation...
are met. Responsibilities: Equipment installation and validation activities (URS, FDS, IQ, OQ, PQ, and VRA) Cleaning validations (IQ, OQ, PQ... activities (URS, FDS, IQ, OQ, PQ, and VRA). Experience with CNC machining and validations (IQ, OQ, PQ). Experience with SAP...
systems. Perform equipment qualifications (IQ), process validations (Process characterization, OQ, and PQ), and gage R&R...
requirements for process implementation and validation (IQ/OQ/PQ). Ensure manufacturing equipment runs at optimal performance...
. Ensure compliance with FDA 21 CFR Part 11 and GAMP guidelines. Manage validation documentation including IQ/OQ/PQ protocols...
systems. Perform equipment qualifications (IQ), process validations (Process characterization, OQ, and PQ), and gage R&R...
, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused... on right first-time execution and continuous improvement. How you will contribute: Lead the execution of CD/PQ/CV/PV/RV...
, commissioning, and support validation activities (IQ/OQ/PQ). Maintain and troubleshoot systems for PW, WFI, Clean Steam, CIP/SIP...
results. Lead validation activities for new products and technologies, including IQ, OQ, and PQ phases. Serve as the QA lead...
, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc. Exposure to Regulatory Audits and Remediation activities... and knowledge in any one of the QC/R&D Lab systems is must. Prepare and execute TP, IQ, OQ, PQ, TSR, Traceability Matrix...