Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for new and existing analytical instruments.
Generate comprehensive and audit-ready documentation for all qualification activities, ensuring compliance.
Conduct tests to verify that instruments function according to manufacturer specifications and user requirements, analyzing the resulting data to confirm accuracy, precision, and linearity.
Collaborate with field service engineers and lab personnel to troubleshoot equipment issues and ensure instruments remain in a qualified state after repairs, software updates, or relocation.
Train laboratory staff on the proper use of qualified equipment and associated standard operating procedures (SOPs).
Support internal and external audits by providing documentation and technical expertise related to instrument qualification.
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