Reporting to: Quality Manager
Sector: PPL (Performance Plastics)
Division: FLS (Fluid Systems
Location: Citywest, Dublin
The Quality Engineer will support the Quality Manager to ensure that the Quality Management System and quality standards of the company are implemented and maintained at the SGLSI Dublin facility in accordance with corporate quality policies, applicable regulatory requirements, ISO requirements, and customer specifications/expectations. The Quality Engineer will also lead the implementation of the site Sterility Programme.
Support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance, including:
– Document control and review/approval of controlled documents
– Change management and review of change controls
– Investigation and CAPA management, including robust root cause analysis
– Complaint management and performance of complaint investigations
– Supplier quality management and performance of supplier audits as appropriate
– Internal audit program and performance of internal audits
– Training program; conduct training when needed
– Implementation of Quality Risk Management in relevant aspects of the QMS
– Management Review
– ISO certification and maintenance
Support the Sterility Project by:
– Writing, executing & reporting of all validation activities
– Commissioning of Process Equipment IQ / OQ / PQ
– Process Design, Development, Optimisation and Validation
– Packaging Validation
– Master Product Assembly Design
– Cleaning Validation
– Gamma Irradiation Process Design
– Perform Risk Assessments
Lead and/or support the oversight of product realisation and commercial manufacturing activities, such as product/specification development, tech transfer, validation, process capability, facilities/utilities/equipment qualification and maintenance, and materials management.
Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product.
Customer support, including:
– Support customer audits, including response and corrective action tracking
– Partner in the resolution of quality issues and customer requests by initiating effective interdepartmental communication.
Practical / Technical Knowledge Required
– Strong knowledge of ISO and/or cGMP requirements and relevant industry standard practices is required. Demonstrated ability to interpret these regulations to ensure proper implementation in the plant systems.
– Strong knowledge of quality systems and product/process lifecycle management within a manufacturing environment.
– Demonstrated understanding of Lean Manufacturing concepts
– Proficient computer skills required including Microsoft Word, Excel, Visio, PPT, and Project
Required Qualifications / Experience
– Bachelor’s Degree in Technical Field.
– 3 + years in regulated industry, such as life sciences, food and beverage, or aerospace with preferred emphasis in life sciences (e.g. pharma, biopharm, or medical device).
– 3+ Quality role (Quality System development, implementation, and/or execution) within a manufacturing environment.
– ASQ Certifications (eg. CQE, CQM, CQA).
– Proven ability to work well in a team environment and model to others essential behaviours, such as initiative, ownership, organisational accountability, and change management. Ability to lead investigations and projects.
– Excellent verbal and written communications skills to interact with internal and external personnel on plant processes, projects, and investigations, and proven ability to exert influence in a directive and positive manner.
– Excellent analytical / problem solving to interpret and understand complex situations in order to determine root cause and implement sustainable corrective actions.
– Driving license needed to travel to / from work and business travel (10% of the time)