Biotech Quality Assurance Specialist
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This role involves managing laboratory systems in a regulated environment. Key responsibilities include authorizing validation life cycle documents, ensuring data integrity through periodic validation and challenge testing, collaborating with vendors for onsite support.
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Additional tasks involve managing change controls, adhering to metrics, supporting data integrity assessments, and participating in technical project teams. Document review, equipment assessment, and ongoing compliance are critical aspects of this role.
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This opportunity offers experience in the dynamic aseptic manufacturing plant at Dun Laoghaire.
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The successful candidate will be responsible for:
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* Planning and executing routine calibration and maintenance of laboratory equipment.
* Tracking and managing all maintenance and calibration activities through CMMS Maximo.
* Authorizing and approving validation life cycle documents.
* Conducting data integrity assessments and business administration of laboratory computer-related systems.
* Scheduling and coordinating equipment repairs and maintenance with vendors/contractors.
* Participating in technical project teams as a subject matter expert on instrument validation regulations and procedures.
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Key requirements include a Bachelor's degree in a science-related field, minimum 3 years of laboratory experience, specific hands-on laboratory equipment lifecycle and validation experience, direct involvement in equipment quality installation or maintenance programs, and strong familiarity with relevant computer applications.
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Demonstrated experience in change control processes and detailed knowledge of methodology, instrumentation, and analytical techniques used for biopharmaceutical testing are highly valued.