SENIOR QC ASSOCIATE

• Operate and/or monitor production activities and support equipment, using MES/DCS and PLC based systems, to ensure optimum equipment uptime and target outputs. Equipment will include, yet is not limited to, parts washers, autoclaves, portable tank CIP/SIP/storage panels, Vial Washer, Depyro Tunnel, Debagger and filling machines.
• Clean room cleaning, housekeeping and materials management in all production areas while focusing on continuous process improvement using Lean Principles.
• Manage equipment flow, including tracking soiled and clean hold times, proper labeling and inventory management of clean and sterile equipment using Kanbans and automated MES system to set QC status and expiry of sterile equipment.
• Maintain process equipment, completing preventative maintenance and equipment troubleshooting and repairs where qualified to perform tasks.
• Participate effectively in writing/revising/ rolling out accurate operational procedures, training materials for various IPT systems; ensure all work is carried out in line with same.
• Support continuous improvement by active participation in investigations and investigation reports, execution/development of change control, and contribution to Kaizen events and projects as appropriate. Perform root cause analysis, using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.

• Minimum Education Leaving Certificate or equivalent required Apprenticeship, Certificate or Diploma preferred; ideally in a related discipline
• Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting.
• Sterile filling processes and equipment
• Knowledge of regulatory/code requirements to Irish, European and International Codes,
• Report, standards, policy writing skills required
• Proficiency in Microsoft Office and job related computer applications required Business Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers
• Understand the specific responsibilities of all Carlow departments as they relate to ones own department, understanding the business processes ones department supports
• Must pass 20/20 vision and color blindness screening.

PE Global