Senior cGxP Laboratory Technician

2 weeks ago

Dublin, Ireland Scientificjobs Full time

Senior cGxP Laboratory TechnicianRK1630DublinContract 6 monthsThe 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 managementDrive 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.

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