QC Specialist

Aphex Group; Dublin; On-site; EUR 70,000 - 90,000; Full time

Job summary

Aphex Group seeks a Technical Services Specialist to own the validation lifecycle for laboratory equipment in a cGMP QC setting. You will manage calibration, requalification, and maintenance, author protocols and summary reports, and ensure documentation is filed in Maximo.

You will support project teams as SME on instrument validation, perform data integrity assessments, and coordinate vendor activities to minimise downtime while maintaining inspection readiness.

Qualifications

• Bachelor's degree in a science-related field required.
• Minimum 5 years in a cGMP laboratory, with exposure to instrument validation and data integrity assessments.
• Knowledge of pharmacopeia methods and analytical techniques used in biopharma QC.

Responsibilities

• Plan, supervise calibration, requalification, and maintenance of laboratory equipment per CMMS Maximo.
• Plan, document, and qualify new equipment in a cGMP environment; write validation protocols and summary reports.
• Conduct periodic reviews of validation lifecycle and audit trails for lab systems.
• Alert QC management on failures; perform impact assessments/investigations as needed.
• Schedule and coordinate equipment repairs with vendors, minimising downtime.
• Act as SME on instrument validation in technical project teams and support change controls.
• Own documentation for Validation Life Cycle across computer-based lab systems.
• Support Data Integrity Assessments for lab systems and related investigations.

Skills

cGMP experience

Analytical instrument validation

Data integrity assessments

Regulatory compliance 21 CFR Part 11

Documentation & validation lifecycle

Project collaboration & change control

Education

Bachelor's degree in a Science related field

Tools

Maximo CMMS

Kneat

ALM

Veeva

Job description

Purpose

The Technical Services Specialist acts as a System Owner / Process Owner for the Technical Services Team. The Specialist is responsible for owning and delivering key quality, qualification and validation lifecycle documentation. The Specialist will support the Team manager in resource planning and resource support.

Planning, executing and documenting all the lifecycle deliverables of laboratory equipment for cGMP Quality Control multi laboratory facilities. The role includes introduction of new lab equipment and changes to existing lab equipment.

The projects include new capabilities and expansion of existing laboratory capacity as part of overall site expansion. The system owner will support all stages of qualification for the associated equipment.

Operational responsibilities will include routine support on existing lab equipment to meet business needs, ensuring inspection readiness and oversight of all service activities carried out by Calibration Technicians. The systems are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo.

Responsibilities

• Planning and supervising routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo. Reviewing & filing of QC calibration & maintenance documentation.
• Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment, including the writing of equipment validation protocols and associated summary reports.
• Conduct periodic reviews and audit trail reviews of as part of validation life cycle of computerised lab equipment.
• Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required.
• Scheduling and coordination of equipment repairs and maintenance with vendors/contractors, while minimising level of down-time for lab equipment, and disruption to laboratory activities.
• Participation in technical project teams to act as a subject matter expert on instrument validation regulations and procedures.
• Where applicable, owns and project manages change controls and adherence to Change Control metrics
• Supporting and managing the addition of project components to Maximo
• Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems
• Any other tasks/projects assigned as per manger's request
• Responsible for authoring/owning, approving, executing all phases of Validation Life Cycle documents for computer related lab systems.
• Responsible for peer reviewing/approving colleague and cross functional teams Validation Life Cycle documents or associated auxiliary documentation relating to system guides or system configuration or vendor qualification/service documentation.
• Responsible for ensuring that all service activities carried out by Calibration Technicians are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo
• Support laboratory investigations, 5 why etc in event of equipment failure / performance issue during analytical analysis.

Knowledge and Experience

• Bachelor's degree in a Science related field is required.
• Minimum of 5 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments.
• Detailed knowledge of pharmacopeia analytical methodology, instrumentation and analytical techniques used for biopharmaceutical testing.
• Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity 21 CFR part 11.
• Demonstrated success in managing an equipment qualification or maintenance program advantageous.
• The successful candidates will be involved with routine activities and may be requested to support project work. For the most part project work consists of the introduction and qualification of analytical equipment for use in routine QC analysis and the candidate should have specific hands-on laboratory equipment lifecycle and validation
• Experience across entire project lifecycle, planning phase, implementation phase and reporting phase.
• Experience of lab computerised system software applications as an elevated user or as a support function to lab during validation activities is an advantage.
• Experience of electronic validation application kneat or ALM is an advantage.
• Experience of document management system Veeva is an advantage.