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. The ability to judge situations accurately and make sound operational decisions to deliver results on time. Continuous Improvement – The ability to continually monitor and review current working practices and make the best use of resources to improve organisational results
The purpose of the role is to:
- Work with production and support functions to maintain and improve our quality systems and adherence to operational best practice thus guaranteeing compliance to external and internal standards
- Develop strong Customer relations through regular interaction with Customers, maintaining a high standard of outcome from Customer audits and by ensuring supply of the highest quality product
- Drive improvement activities to support quality and financial performance, lead key improvement projects evolving through customer requirements, legislative changes and amendments of the Pharmaceutical code to ensure compliance with standards and accreditation audits.
- Where necessary draft, review and implement changes to our quality system, standard operating procedures and policies to satisfy customer and third party requirements
Key responsibilities - Quality
- Review the quality system as appropriate to ensure full compliance with customer and company best practice guidelines and maximize 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 re-occurring 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 quality system and ensure optimum process in place to meet customer specifications whilst maximizing production
- Review amendments to standards and ensure compliance with accreditation bodies
- Support 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 site, customers and corporate as required
- Identify improvement projects and continuous improvement initiatives in line with 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
The Ideal Candidate:
- Minimum 5 years’ experience in a Quality role at a senior or management level
- Graduate Calibre, 3rd level Degree
- H&S qualification desirable
- Internal Auditor qualification
- Working and audit knowledge of ISO 9001, PS 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
- 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 recognised 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
For further information on this Assistant Quality Manager role in Mayo please contact Orla on 0860449473/ Talent@hero.ie
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