Quality & Validation Manager

My client is a seeking a Quality & Validation Manager to join their Waterford plant. As the Quality Manager, you will work closely with Planning, Production and Engineering to ensure programs are aligned to meet site and customer standards.  In your role, you will manage the Quality Engineering team, Document control and QC Inspectors.

Your Responsibilities:

• Establishing in-house standards for quality.
• Oversee the design and execution of commissioning and validation protocols on manufacturing equipment, software, and process, and approve validation documentation.
• Remain up to date with ISO requirements and ensure the company is audit-ready.
• Plan and monitor internal audit schedule.
• Coordinate validation activities to ensure schedule adherence and compliance.
• Using statistical analysis, measures, control, and improve product and process.
• Quality system development, implementation & maintenance.
• Ensuring that processes meet with ISO and AS requirements.
• Assessing product specifications and customer requirements and ensuring they are met.
• Monitoring performance by gathering data and producing reports.
• Supervising the programme of internal auditing and calibration.
• Development, maintenance, and approval of systems & standards.
• Managing quality issues to ensure timely and effective corrective actions to prevent reoccurrence.
• Providing support to regulatory and customer audits.
• Monitoring the ongoing performance and outputs of the quality process and providing updates to managers and directors around quality issues.
• Supplier and Customer Liaison on quality issues.
• Provide validation expertise to maintain validated status for the facility.
• Maintain an understanding of cGMP regulations and guidance in relation to all aspects of qualification of process and equipment.
• Proactively develop sustainable goals and targets for each team within the area.
• Conduct Performance reviews, RTW, probation reviews, etc.
• Develop your team and expand by hiring additional staff.
• Design, maintain, and implement training programmes as agreed with management.

The successful candidate will have:

• Degree Qualification in Scientific/technical discipline; Postgraduate degree is highly desirable.
• 10 + years of quality experience in a manufacturing environment.
• 5+ years of experience as Quality Manager or Validation Manager with staff management.
• Experience in quality systems management.
• Strong understanding of ISO:13485 & ISO:9001
• Experience in subcontract manufacturing with numerous product lines.
• Experience gained in an FDA regulated environment is desirable.

For further information on this role Quality Manger role, please contact Marchon Monroe on 086 044 9473/ talent@hero.ie

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Marchon Monroe

JOB-11402