Senior QC Specialist

Life Science Recruitment; Dublin; On-site; EUR 65,000 - 82,000; Full time

Job summary

Life Science Recruitment is recruiting for an award-winning pharmaceutical organisation in Dublin. The role covers planning, executing and documenting calibration, qualification and routine maintenance of laboratory systems for cGMP QC labs at the site.

You will ensure calibration activities tracked in CMMS Maximo; author/own validation life cycle documents; collaborate on data integrity testing; may support project work involving equipment qualification and validation.

Qualifications

• Bachelor's degree in science with 3+ years of laboratory experience in a cGMP environment.
• Knowledge of instrument validation, data integrity assessments, and regulatory requirements.
• Experience with calibration and maintenance of laboratory equipment.
• Exposure to analytical instrument validation in pharma or biopharma.

Responsibilities

• Plan, execute and document calibration, requalification and maintenance of laboratory equipment per CMMS Maximo.
• Lead qualification of new equipment, writing validation protocols and summary reports.
• Review instrument validation as part of the validation life cycle.
• Coordinate repairs with vendors and minimize downtime.
• Support project teams as SME on instrument validation regulations.
• Manage change controls and data integrity assessments for lab systems.

Skills

Laboratory calibration

cGMP compliance

Data integrity testing

Validation lifecycle management

Equipment validation

Education

Bachelor's degree in science

Tools

Maximo CMMS

Job description

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

This role will be responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities at the site. Responsible for ensuring that all maintenance & calibration activities carried out by Calibration Technicians are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo.

They will be responsible for authoring/owning and approving Validation Life Cycle documents for computer related systems including responsibility for Data Integrity testing and business administration of Laboratory Computer Related systems.

This person will be 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.

Responsible for:

• Planning and conducting 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 of instrument validation as part of validation life cycle.
• 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 minimizing 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 CMMA Maximo
• Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems

Education and Skills:

• Bachelors degree in a science discipline with 3+ years of laboratory experience in a cGMP laboratory environment (pharma or biopharma industry) including exposure to analytical instrument validation and data integrity assessments.
• Detailed knowledge of the methodology, and instrumentation and analytical techniques used for biopharmaceutical testing.
• Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
• Demonstrated success in managing an equipment qualification or maintenance program advantageous.