Responsibilities: Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols... compliance with FDA 21 CFR Part 820, ISO 13485, and GMP regulations. Partner with R&D, Quality Assurance, and external vendors...
Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Author..., Quality Assurance, Manufacturing, Automation, and Regulatory teams. Mentor junior validation engineers and specialists...
needs across clinical research, pharmacovigilance, regulatory affairs, quality assurance, quality control, medical affairs... with equipment vendors;soliciting observations from operators. Able to work with Surface Mount Technology, Selective Soldering, IQ...
, workflow documentation, and quality assurance processes for bioinformatics analyses Mentor junior bioinformaticians... automated quality assurance and quality control monitoring throughout analytical pipelines Develop statistical methods...
Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Author..., Quality Assurance, Manufacturing, Automation, and Regulatory teams. Mentor junior validation engineers and specialists...
and confidence in the areas of Quality Assurance and validation/verification (V&V). Key Responsibilities Provide focused... and methods including project management, process design, document generation (IQ, OQ, PQ, SOPs, WIs and ETSs), critical process...
strong hands-on experience executing IQ, OQ, PQ, and test scripts;documenting objective evidence;managing protocol... environment, coordinate closely with QC laboratories, Quality Assurance, IT/OT, automation, vendors, and manufacturing...
Manufacturing, Quality Assurance, Validation, Regulatory Affairs, Engineering, Supply Chain, and IT. Ensure project activities...) activities including validation planning, risk assessments, IQ/OQ/PQ coordination, and documentation review. Facilitate project...
: Quality Assurance Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America... to implement and validate new Equipment Control software. Implement IQ and Calibration requirements in accordance...
. Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports... with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems...