QC Lab Systems Specialist

  • Contract
  • Cork

Website Ref: TPM03663

Summary:
A biotech company in West Cork requires a QC Lab Systems Specialist.

Responsibilities:

  • Responsible the qualification, maintenance, and/or integration of the QC systems, in compliance with up-to-date data integrity, regulatory, and industry standards.
  • Accountable for change control process and mechanisms required to maintain a state of continued compliance for the QC systems.
  • Support instrumentation or software troubleshooting, investigations, and deviations as a lab systems SME.
  • Manage deviations, CAPA’s and change control’s related to the QC and team priorities.
  • Serve as an SME for regulatory and internal inspections and audits.
  • Provide technical expertise and coaching to support lab operations.
  • Lead the delivery and of projects whilst adhering to project timelines through the use of project management tools.
  • Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.

Qualifications & Experience:

  • A bachelor’s degree in Engineering, biological science, or related field.
  • Strong CSV experience with analytical instrument qualification and computer systems implementation.
  • Excellent comprehension 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 appreciation of the change management requirements of validated systems and software.
  • Excellent communication skills both verbal and written.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.