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Apply for this job
Details
Senior cGxP Laboratory Technician
Reference: | RK1630 | Location: |
Dublin |
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
Laboratory Scientist
Senior cGxP Laboratory Technician
RK1630
Dublin
Contract 6 months
The Senior cGxP Laboratory Technician plays a pivotal role in ensuring that all laboratory operations, infrastructure, and documentation align with global regulatory requirements and internal quality standards. This position serves as a subject matter expert (SME) in cGMP, GLP, and GDP compliance, driving continuous improvement across laboratory systems and practices.
Duties:
- Ensure all laboratory activities comply with global cGxP standards, internal SOPs, and applicable regulatory requirements.
- Lead compliance remediation programs and implement corrective and preventive actions (CAPAs) to address audit findings or process gaps.
- Maintain and update documentation systems, ensuring traceability, data integrity, and adherence to quality management principles.
- Oversee laboratory infrastructure maintenance, equipment qualification, calibration, and lifecycle management
- Drive standardization of laboratory processes to enhance efficiency, reliability, and reproducibility of analytical testing and support activities.
- Support change control, deviation management, and risk assessments related to laboratory operations.
- Provide technical guidance, coaching, and mentorship to junior laboratory staff to build compliance awareness and technical capability.
- Serve as a subject matter expert during internal and external audits, inspections, and quality reviews.
- Partner with Engineering, Validation, and Facilities to ensure proper integration of laboratory systems and support services.
- Collaborate with Quality Assurance on compliance strategy, document control, and audit preparation.
- Contribute to cross-site harmonization efforts and knowledge-sharing initiatives.
- Identify opportunities for process optimization, digitalization, and automation within the lab environment.
- Lead or participate in projects aimed at enhancing data integrity, efficiency, and compliance maturity.
Educational and Experience
- Bachelor’s degree (or higher) in a scientific discipline (e.g., Chemistry, Biology, Biomedical Engineering, or related field).
- Minimum of 5 years of experience in a regulated laboratory environment (medical device, pharmaceutical, or biotech).
- Deep understanding of cGxP principles and regulatory frameworks (FDA, ISO 13485, EMA, MHRA, etc.).
- Proven track record in remediation, audit readiness, and continuous improvement initiatives.
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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