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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.
Laboratory Scientist Cork PhD Pharmaceutical Product Development Engineer Packaging Engineer Chemistry Scientific IT Manufacturing Executive Cork City Connected Health Biotechnology Diagnostics Quality Control Medical Affairs Sales and Marketing Quality Assurance Academic Life Science Biopharmaceutical Allied Healthcare Microbiology Mayo Academic Supply Chain Medical Device Project Manager Validation Engineer Dublin Clinical Research Sales and Marketing Quality Engineering Supply Chain Engineering Scientist Limerick Pharma Sales
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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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