As a QC Instrument Specialist, you will play a crucial role in maintaining quality control systems and instrumentation according to the latest data integrity, regulatory, and industry standards. This exciting opportunity is ideal for someone with a strong background in CSV and/or CQV for laboratory systems and instrumentation.
About this Opportunity:
This 12-month contract position offers the chance to work on a large-scale facility project in Dublin, contributing to the development of a life-changing treatment. You will be part of a collaborative team responsible for troubleshooting, investigations, and deviations as an SME.
Key Responsibilities:
* Maintain and update quality control systems and instrumentation to ensure compliance with up-to-date data integrity, regulatory, and industry standards.
* Support the QC department in troubleshooting, investigations, and deviations related to QC systems and instrumentation.
* Author and revise local SOPs, work instructions, and guidelines to ensure accuracy and consistency.
* Manage deviations, CAPAs, and change controls related to QC systems and instrumentation and prioritize tasks accordingly.
Required Skills and Qualifications:
* Bachelor's degree in Engineering, biological science, or a related field.
* At least 3 years' experience in CSV and/or CQV for laboratory systems and instrumentation.
* Strong knowledge of biologics analytical methods and specifications and Good Manufacturing Practice (GMP).
* Familiarity with regulatory audits and ability to support the QC department accordingly.
About this Role:
This role is ideal for someone looking to develop their skills in a fast-paced project environment while working with cutting-edge technologies. You will have the opportunity to contribute to the manufacturing of a life-changing treatment and work collaboratively with a top-ranked team.