Website Ref: TPM03663
A biotech company in West Cork requires a QC Lab Systems Specialist.
- 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 email@example.com.