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Showing 8 jobs
Skills:
Installation Qualification (IQ), Factory Acceptance Testing (FAT), Operational Qualification (OQ), Site Acceptance Testing (SAT), Good Manufacturing Practices (GMP), Performance Qualification (PQ), Process equipment qualification, GAMP 5, Cleanroom validation
Skills:
Water for Injection (WFI), Purified Water (PW), EMA), Regulatory requirements (FDA, PDA), Industry standards (ISPE, Clean Steam, Quality System, Risk-based approaches to commissioning and qualification validation, Clean utilities, Ehs, Qualification validation
Skills:
Filtration, deltav, Equipment Qualification, Life Sciences, Performance Qualification, Quality Assurance Procedures, Validation Procedures, Biomedical, Qualification Process, Emerson DeltaV
Skills:
computerized system validation , Test Scripts, Process Validation, cleaning qualification, qualification documentation, single-use material qualification, commissioning qualification, CQV equipment qualification, validation activities, data integrity, Instrumentation, qualification protocols, validation software
Skills:
Site Acceptance Testing (SAT), Mechanical Completion (MC), Process Flow Diagrams, Commissioning procedures, Control narratives, Plc, Functional Verification, Equipment Layouts, Packaged process skids, P&IDs, Automated process equipment, I/O checks, process equipment, SCADA
Skills:
Pharmaceutical engineering standards, Risk Based Validation, Field CQV execution
Skills:
GMP regulations, P&ID review, CIP system design and operation, FAT/SAT execution, Commissioning and Qualification, Technical Report Writing, Cleaning validation principles
Skills:
Clean Steam, Hvac, GAMP 5, ISPE Baseline Guides, CQV Lifecycle Management, Fda, process machinery, Gmp, WFI, EMA, cleanroom environments
