We’re currently recruiting for an exciting opportunity with a pharmaceutical organization based in Cork. 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.

Duties

The QC Leader will be responsible for leading/supporting the QC team in their daily activities along with the various tasks outlined below.

• Supporting staff to plan their workloads, rotas and organise ongoing QC resources
• Hosting the laboratory tours and presenting data during Customer audits or Regulatory Inspections
• Ensuring information is communicated and fed back effectively to the relevant parties in a timely manner to guarantee all parties are kept fully informed.
• Responsible for the training modules of QC employees on laboratory methods, laboratory SOPs and correct laboratory techniques
• Interpret data and use as a basis for routine decision making and actions.
• Participate in root cause analysis and risk assessments (where appropriate)
• Monitor and trend laboratory data
• Review, update and approve laboratory SOPs
• Review, update and approve specifications and analytical methods
• Responsible for the API Stability program
• Oversee Cleaning validation and verification studies
• Ensure maintenance and calibrations on laboratory equipment are performed
• Troubleshooting on Laboratory equipment
• Responsible for the introduction and qualification of new equipment in the laboratory
• Responsible for backup and restore procedures in the laboratory
• Ensure all instruments meet data integrity standards
• Responsible for Change controls and CAPAs generated in the QC department

• Strong work experience in the pharmaceutical or related industry
• Experience in a senior or supervisory role
• Excellent interpersonal and leadership skills
• Ability to lead the QC Team during Investigations and trouble-shooting