Collins McNicholas

This company is packaging solutions for the branded and healthcare markets and has been established for over 14 years. Now seeking a Quality Manager to join their business on a permanent basis in Mayo.

The role focuses on compliance, customers and continuous improvement activities to create a total quality culture and reduce quality costs in line with best practice procedures.

Key Responsibilities

  • Review the quality system as appropriate to ensure full compliance with customer and company best practice guidelines and maximize the effectiveness of production contributing to consistent operational performance and standards whilst ensuring conformance to ISO9001:2008 and PS9000:2001 and environmental standards and accreditations
  • Provide authoritative guidance and advice on all aspects of quality to the site management team and employees; train and coach employees improving knowledge and skills in quality improvement
  • Recruit, develop, motivate and manage a QA team that optimises quality operations and is flexible in the support it offers the business, meeting current and future needs
  • Establish and develop professional working relationships with customers, providing a technical service and reference point as required to support the company’s products and reputation as a quality supplier
  • Manage the customer complaint procedure; facilitate the investigation of quality problems, faults and non-conformances with production teams; manage corrective and preventative problems to ensure quality standards are maintained. Initiate and control robust investigations to provide corrective and preventive actions (CAPA) and support the complaints handling process and participate in implementing improvement actions to prevent reoccurring issues.
  • The facilitation of customer-facing activities and communications including customer visits, responses, and preparation of information whilst leading site audit activities (external body, internal and customer)
  • Lead quality initiatives and focus groups to support knowledge and understanding of all operatives and grow awareness of quality issues to improve quality
  • Promote a total quality philosophy at all levels developing a culture of right first time and continuous improvement
  • Develop an Integrated Quality Management System including quality and environmental

 

Key Responsibilities – Business Improvement

  • Lead improvements to enhance the quality system and ensure the optimum process in place to meet customer specifications whilst maximizing production
  • Review amendments to standards and ensure compliance with accreditation bodies
  • Support the introduction of new equipment on-site and validation processes to meet safety and customer expectations
  • Take on other projects and responsibilities as required.
  • Contribute ideas and participate in ongoing business improvement initiatives to reduce overall operating costs, improve margin and provide input into the strategy and operations of the site.

 

Key Responsibilities – Other 

  • Manage the environmental management system to maintain ISO standards and accreditations and lead regular assessment audits
  • Produce data and present reports for the site, customers and corporate as required.
  • Identify improvement projects and continuous improvement initiatives in line with the site and corporate requirements to improve quality and safety and work with colleagues to implement these
  • Support senior leadership team in introducing systems and procedures to enhance operating effectiveness and efficiencies
  • Deliver GMP, FSC, Environmental and H&S training to all employees as required
  • Take on other projects and responsibilities as required.

Qualifications

  • 3rd level Degree
  • H&S qualification desirable
  • Internal Auditor qualification.

 

 Knowledge, Skills & Experience

  • Minimum 5 years experience in a Quality role at a senior or management level
  • Working and audit knowledge of ISO 9001, PS 9000, 18001 and 14001
  • Experience in a manufacturing/production environment ideally with experience within a pharmaceutical environment and knowledge of Industry standards and guidelines
  • Demonstrable experience of leading change and implementing continuous improvement processes.
  • Supervisory experience/people management
  • Demonstrable experience of validating new equipment and processes
  • Knowledge of Good Manufacturing Practices (GMP).
  • Project management and problem-solving skills such as 6 Sigma, or another recognized Business Improvement Technique.
  • Root cause analysis and problem-solving techniques
  • Customer relations skills
  • Skilled in information handling, analysis, and presentation
  • Competent in using Microsoft Office packages

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