At Lonza, we believe that talented people working together can achieve great scientific solutions. Our greatest asset is our employees, who devise innovative ideas to help businesses improve lives around the world. In exchange, we empower our people to own their careers and make meaningful contributions.
Key Responsibilities
* Represent QA Qualification in project organizations for new facilities or projects, ensuring compliance with qualification of facilities, utilities, equipment, and systems.
* Coordinate various QA interests during project phases, focusing on process, cleaning, and other relevant objectives.
* Develop and implement new qualification strategies, making key decisions as needed.
* Compile, review, and release Qualification Documents (URS, Qualification Plan & Report, DQ/IQ/OQ/PQ Reports, etc.) and support quality risk analysis (e.g., FMEA).
* Evaluate and approve technical change requests throughout a project's lifecycle, assessing their impact on facility, equipment, utility, and system qualification.
* Represent qualification topics during customer audits and regulatory inspections.
* Prioritize and drive CAPA and Effectiveness Checks items to completion, ensuring timely closure and accurate recording of deviations in Deviation Reports.
Requirements
* Mastery of Engineering, Chemistry, Biotechnology, or a related field through a Master/Bachelor degree.
* Significant experience in the pharmaceutical industry, preferably in a QA role.
* Strong understanding of applicable cGMP regulations.
* Familiarity with engineering and manufacturing processes.
* Ability to oversee project execution, identifying non-compliance with quality standards.
* Fluent language skills in German and English are required.