Qualification Expert

Key Responsibities:

• Develop and implement qualification strategies and plans for laboratory instruments and equipment, ensuring activities are aligned with applicable GMP requirements, internal procedures, and the intended use of the equipment.
• Perform risk assessments and equipment classification to determine the appropriate qualification approach and define the required level of testing and documentation based on instrument criticality and GMP impact.
• Lead the preparation and review of User Requirements Specifications (URS), ensuring that business, technical, compliance, and data integrity requirements are clearly defined and traceable throughout the qualification lifecycle.
• Develop, review, coordinate, and execute qualification protocols, including IQ, OQ, and PQ activities, and ensure that deviations, observations, acceptance criteria, and qualification results are appropriately documented and resolved.
• Support the qualification of computerized laboratory instruments and associated software, ensuring that system functionality, interfaces, access controls, electronic records, and applicable data integrity requirements are adequately addressed.
• Maintain requirements traceability and qualification reporting, ensuring that qualification evidence demonstrates that user requirements have been successfully verified and that equipment is suitable for its intended use.
• Coordinate qualification activities with vendors, service providers, engineering, laboratory users, QA, maintenance, and calibration teams, including management of changes, requalification requirements, periodic reviews, and lifecycle activities.
• Maintain oversight of the instrument inventory and qualification status throughout the equipment lifecycle, ensuring continued qualified status through calibration and maintenance interfaces and supporting equipment retirement and decommissioning when required.

Essential Requirements

• 7+ years overall experience in pharmaceutical/biopharmaceutical laboratory equipment qualification, validation or engineering.
• 5+ years hands-on qualification experience in GMP/GxP environments.
• Demonstrated independent experience qualifying both conventional laboratory equipment and computerized analytical systems.
• Bachelor's or Master's degree in Instrumentation Engineering, Electronics/EEE, Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Analytical Chemistry, Biotechnology, Chemical Engineering, or a closely related technical/scientific discipline.
• Knowledge of GAMP-based computerized-system concepts is also highly desirable because the laboratory-equipment qualification procedure explicitly addresses GAMP software categories in configuration/qualification considerations.