Full Time, Medical/Pharmaceutical/Scientific Vacancy In City of Dublin
QC Maintenance Instrumentation Systems Specialist
Working as part of a dynamic team to plan, execute, and managing the activities required to maintain the testing infrastructure of the QC lab. This is a Dublin based role with a leading Biotech multinational
Key Responsibilities
* Responsible for the maintenance of the QC systems and instrumentation, in compliance with up-to
* date data integrity, regulatory, and industry standards
* Responsible for change control process and mechanisms required to maintain a state of continued
* compliance for the QC systems and instrumentation.
* Support the QC department for troubleshooting, investigations, and deviations as an SME.
* Manage deviations, CAPA’s and change control’s related to QC systems and instrumentation and team
* priorities.
* Author and revise local SOPs, work instructions, and guidelines.
* Serve as an SME for regulatory and internal inspections and audits.
* Motivation to be an inspiring member of a high performing team with the desire to continuously learn, improve, and develop.
Education and Qualifications
* A bachelor’s degree in Engineering, biological science, or related field.
* Typical Minimum Experience:
* 3 years’ experience in CSV and/or CQV for laboratory systems and instrumentation
* Experience in regulatory audits.
* Working knowledge of biologics analytical methods and specifications and Good Manufacturing Practice (GMP).
* Strong CSV experience with analytical instrument maintenance
* Excellent understanding of data integrity compliance requirements
* Experience and understanding of the change management requirements of validated systems and software.
* Excellent communication skills both verbal and written
2024-04-09 08:44:27
Apply For This Dublin Medical/Pharmaceutical/Scientific Job Vacancy - Here
Updated 16-04-2024 10:30
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