QC Instrumentation Specialist
Posted 09/04/2024 by Headcount Solutions Limited
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.
- Type:
- Contract
- Contract Length:
- N/A
- Contact Name:
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- Telephone:
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- Job Reference:
- NHBT99
- Job ID:
- 220934489
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