Position Overview
Summary:
We are seeking a detail-oriented and experienced Equipment Qualification Contractor to support the qualification of laboratory equipment in compliance with cGMP and regulatory standards. The contractor will be responsible for executing qualification protocols (IQ/OQ/PQ), preparing documentation, and ensuring equipment is fit for intended use in a pharmaceutical quality control environment.
Key Responsibilities:
β’ Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
β’ Collaborate with cross-functional teams (QC, QA, Engineering, Validation) to ensure timely and appropriate qualification.
β’ Prepare and maintain User Requirement Specifications (URS) and Design Qualification (DQ) documentation.
β’ Ensure all qualification activities are documented accurately and meet FDA, EMA, and ICH guidelines.
Education & Experience...