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Paula O'Reilly
Life Science

+353 1 507 9265
[email protected]
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Details

Quality Manager


Reference:POR/703483 Location: Wexford
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Manager

A Quality Manager is required to join a leading manufacturing business based in County Wexford. Leading the Quality Team, you will be instrumental in overseeing and enhancing the company's quality management system and quality assurance protocols. This role is pivotal in ensuring that all products and processes meet stringent industry standards including food, wastewater utilities and pharmaceutical industry standards, particularly focusing on product inspection and verification along with validation processes, regulatory inspections, customer audits, and independent regulatory audits. A robust approach to Corrective and Preventive Action (CAPA) management and fostering a culture of continuous improvement is a key aspect of the role.


The Role

  • Develop, implement, and maintain quality assurance policies and procedures aligned with customer’s needs, industry standards and regulatory requirements.
  • Oversee auditing, testing and validation activities, including equipment qualification, process validation, and metal finishing and cleaning validation, ensuring compliance with Good Manufacturing Practices (GMP).
  • Coordinate and manage internal and external audits, facilitating both customer and regulatory inspections, and ensuring timely resolution of any findings.
  • Lead the CAPA program by identifying root causes of non-conformances, implementing corrective actions, and verifying their effectiveness.
  • Promote a culture of continuous improvement by implementing Lean methodologies and Six Sigma principles to enhance process and product quality along with operational efficiency. This should be heavily weighted toward visual standards, quality training, inspection skills training, and continuous reviews of Inspection criteria and capability.

The Person
  • Bachelor’s degree in engineering, science, quality management, or a related field.
  • Minimum of 5 years' experience in a quality management role within the pharmaceutical equipment manufacturing or related or equivalent general manufacturing industry such as Agri, Automotive or Aerospace.
  • In-depth knowledge of GMP, ISO 9001:2015, and ISO 14001:2015 standards and GDP.
  • Proven experience with Quality assurance management, CAPA management, and regulatory inspections.
  • Excellent project management skills.
  • Strong analytical skills with the ability to interpret complex data to identify problems and drive actionable corrective actions to resolve systemic problems.
  • Excellent communication and interpersonal skills, capable of leading cross-functional teams and interacting with regulatory bodies. Proficiency in quality management software and Microsoft Office Suite with a particular expertise around excel would be advantageous.

For further details please contact;Paula O’Reillyon 087 7094141 or send CV in confidence to [email protected]