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QC Instrumentation Systems Specialist

  • Job reference: 935987
  • Location: Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 10/06/2021

Orion Group Life Sciences have an exciting opportunity for a Quality Control (QC) Instrumentation Systems Specialist for our Multinational Biopharmaceutical client in North Dublin on an initial 11-month contract.


Job Purpose

The role of Quality Control (QC) Instrumentation Systems Specialist operates as part of a dynamic team to plan, execute, and managing the activities required to maintain the testing infrastructure of the QC lab.

Reports to: QC Lab Systems Lead

Responsibilities

Responsible the qualification, maintenance, and/or integration of the QC systems, 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 the QC and team priorities.

Assist with implementation of MSD Quality Chapters to ensure we maintain best practices and build excellence into our QC systems and processes.

Author and revise local SOPs, work instructions, and guidelines.

Core Requirements

  • Strong CSV experience with analytical instrument qualification and computer systems implementation.
  • Excellent understanding of data integrity compliance requirements
  • Demonstrated ability to drive complex tasks to completion.
  • Strong organizational, problem-solving, and continuous improvement skills
  • Ability to prioritize Lab Systems activities in line with the project schedules and business needs.
  • Ability to maintain the flexibility to react to changing business needs.
  • Experience and understanding of the change management requirements of validated systems and software.
  • Excellent communication skills both verbal and written.
  • Ability to handle multiple projects and deliver on critical deadlines.
  • Demonstrated ability to work independently on own initiative and manage time.
  • Demonstrate ability to work with a team and co-ordinate work to meet a common goal.

Education:

A bachelor's degree in Engineering, biological science, or related field.

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 of GMP

For more information on this role, call Dan on +353 868140295 or email Daniel.Ryan@orioneng.com for a completely confidential chat about this role and other opportunities.


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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