Senior Recruitment Consultant at Life Science Recruitment - Supply Chain ~ Quality ~ Manufacturing
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 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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