We are looking for a Senior Technical Analytical Specialist to join our Technical Operations Team, at our Active Pharmaceutical Ingredients manufacturing site in Sligo. The successful candidate will be the the primary technical authority for analytical laboratory operations across routine and advanced testing, with accountability for compliance, verification, laboratory infrastructure, and support for the new laboratory. The role combines technical stewardship with laboratory coordination to ensure analytical activities, documentation, equipment, and systems consistently meet or exceed regulatory, quality, and safety standards.
Role and Responsibilities
- Provide analytical testing and technical support for routine, non-routine, and advanced applications, ensuring testing meets product, safety, and quality requirements.
- Lead compliance verification for analytical results, methods, equipment, records, and data to ensure alignment with internal standards and external requirements, including cGMP, GLP, ICH, FDA/HPRA, and EHS.
- Author, update, and maintain SOPs, protocols, and technical records to support audit readiness and regulatory compliance.
- Oversee laboratory infrastructure, including asset management, equipment purchasing, qualification, maintenance, and workflow optimization, particularly for new laboratory spaces.
- Perform advanced troubleshooting, technical investigations, and support method validation, transfer, and integration activities.
- Collaborate with R&D, MS&T, Quality, Process, EHS, and Lab Management to support knowledge transfer and operational alignment.
- Mentor and coach analysts and project teams on compliance, verification, laboratory operations, equipment use, and best practices, without formal people management responsibilities.
- Support internal and external audits, regulatory inspections, CAPA development, and quality system initiatives.
- Drive continuous improvement in compliance, documentation, workflow efficiency, process modernization, and laboratory systems.
- Ensure equipment is qualified, maintained, and used in line with compliance and safety standards, with complete audit-ready documentation.
- Conduct calculations, report findings, and escalate analytical or verification issues supporting high-impact investigations and improvement projects.
- Identify and help resolve safety hazards and non-compliance issues in coordination with EHS and Lab Management.
- Maintain accurate, complete, and current records for all laboratory activities.
- Complete handover of validated analytical methods to QC, ensuring smooth transfer of knowledge, protocols, and compliance requirements.