, 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...
execution (IQ/OQ/PQ), documentation, and ongoing compliance monitoring. Ensure lab systems meet FDA 21 CFR Part 11, EU GMP...
that focuses on equipment validation. Roles & Responsibilities Develops, prepares, and executes IQ, OQ, and PQ protocols...
),and PQ (Performance Qualification). Documentation & Compliance: Author, review, and approve validation documentation... Management) and ISO 14971 (Risk Management). * Validation Expertise: Proven hands-on experience with IQ, OQ, and PQ protocols...
, 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...
Plans, Requirements, Specifications, Assessments, Test Scripts (IQ/OQ/PQ or equivalent), Summary Reports, Trace Matrices...
processes. Experience supporting equipment qualification (IQ/OQ/PQ). Experience with aseptic processing, HVAC systems...
and validation documentation including IQ, OQ, PQ, PPQ, Validation Master Plans, risk assessments, calibration records, and periodic...
, including Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis Work...
Knowledge of FAT, SAT, IQ, OQ, PQ, or other validation/qualification methodologies Experience with CMMS, ERP, or engineering...