Qc Instrumentation Specialist, Dublin

Last update 2024-04-14
Expires 2024-05-14
ID #2098655132
Qc Instrumentation Specialist, Dublin
Ireland, Dublin, Dublin,
Modified April 3, 2024


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

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Qc instrumentation specialist

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