Job Description

Job Purpose

The Quality Systems Project Specialist is responsible for providing guidance and support of validation for new processes, materials systems, and software. Knowledge of and adherence to regulatory compliance for implementation is required while identifying and adopting best practices across EMEA.


This role will partner with Food Safety and Product Stewardship teams to increase knowledge and capability, provide administration support and provide solutions to expediate these critical processes. In addition, this role has a key responsibility to create, deliver, support development, integration, implementation, and central reporting as related to all facets of the quality management systems.

Job Responsibilities/Key accountabilities:

Assure requirements of development and implementation of validation activities process improvement activities are executed within compliance to regulatory requirements commensurate to the protection of Smurfit Westrock and satisfaction of the customers serviced within the Consumer packaging sector. Support Food Safety and Product Stewardship with building database platforms and finding solutions to execute responses to customer to meet customer requirements and maintain database for suppliers and internal stakeholders Build Food Safety and Product Stewardship training and support execution of this training across EMEA & APAC Develop the eQMS infrastructure to support the digital QMS execution, training, and updates across EMEA. + Provide monthly reporting for EMEA Quality metrics
+ Track all Support activities in eQMS



Manage all changes and updates to standardised QMS platforms, to ensure compliance evidenced by the output of appropriate documentation and validation activities suitable to such changes and updates. Build capability in software validation requirements as it relates to innovation projects. Support the Innovation team, provide guidance on projects as it related to materials and testing requirements. Build processes, to support the innovation team reporting. Develop, understand, and execute onboarding new systems for quality, including, but not limited to. Digital DOC, Laboratory systems, and digital COA implementations across EMEA. Ensure consistency across all sites GMP, Testing, Documentation, Templates and Customer Communication Support introduction of significant operational projects through providing expertise in the framework required to achieve quality compliance. Such projects may include ERP roll out programme, digital batch record, Prepress transformations, and new printing technologies Lead and support ad hoc customer projects for problem solving process capability or quality improvements across EMEA. Develop standard key account presentations and data analysis for monthly customer reporting Produce data and present reports for site, customers and corporate as required.
Develop and improve processes in Food Safety and Product Stewardship to support the QM and the site teams on a key requirement to self-service effectively Lead improvements to enhance business transformation projects Support introduction of new equipment on site and validation processes to meet safety and customer expectations Identify improvement projects and continuous improvement initiatives in line with site and corporate requirements
Support senior leadership team in introducing systems and procedures to enhance operating effectiveness and efficiencies

Knowledge, Skills, Experience

Minimum 3 years' experience in Materials Science and or/Quality role Demonstrable success with stakeholder management Process Engineer background or prove success in business process improvement Essential strong English communications skills verbal and written. Desirable second European language Working and audit knowledge relevant accredited standards - Pharma/Food Experience in a manufacturing/production environment ideally with experience and knowledge of Industry standards and guidelines. Demonstrable experience of leading change and implementing continuous improvement processes. Management experience Demonstrable experience of validating new equipment and processes Knowledge of Good Manufacturing Practices (GMP) Project management and critical thinking skills such as 6 Sigma, or another recognised Business Improvement Technique Root cause analysis and problem-solving techniques Customer relations skills Excellent skills in information handling, analysis, and presentation Excellent skills in using Microsoft Office packages.

Behaviours

Analytical thinking Self-Control Tenacity Rational Persuasion Efficiency Focused Concern for standards and Results focused. Communication/briefing skills Negotiation/consultation skills Commercial awareness

Other Requirements

Flexible and adaptable to change and prepared to take on additional responsibilities with other duties as required to meet business needs. Successfully adapts to changing demands and conditions. Be able to be self-motivated, standards driven, with a keen eye for detail whilst being team focused and harnessing collaboration and co-operation of others. This role will require travel across EMEA as required.