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Overview of Role: Our client based in North Dublin is seeking a Senior Quality Engineer & Deputy Responsible Person Quality on a full-time permanent basis.
Main purpose of job: Quality & Continuous Improvement Manager & Responsible Person (RP) Quality: This person will work primarily with the customer to ensure a smooth supply chain for our customers.
Main tasks/responsibilities:
Quality:
Pro-actively work with all customers to ensure the company is continually meeting and exceeding their requirements.
Keep appraised of all new developments, technologies pertaining to company development goals and foster continuous improvement ethic.
Liaise with all functions to continuously interrogate the systems & processes eliminating waste and improving performance.
Provide support to internal departments regarding process development and process risk analysis and assess new processes for effective quality control.
Ensure processes enhance overall Quality performance and assure that all customer and regulatory agency requirements are met.
Drive solutions to improve consistency in KPl's using Continuous improvement & Lean manufacturing tools.
Ensure daily, weekly and monthly monitoring on all aspects of quality system and customer complaints is conducted Deputy RP Support RP in relation to
Attend and participate in the GDP training provided by the RP and other external organisations
Review and train on all procedures relating to distribution activities covered under the WDA
Ensure that a system is in place to manage documentation and ensure that adequate records are maintained in a secure manner
Ensure the principles of Good documentation Practices are applied to documentation
Ensure that Change Control systems are established and implemented.
Ensure there is a Falsified Medicines procedure in place to assist in identification of potential
Ensure there is an adequate training system in place and assist in training the staff in GDP principles, Legislation and HPRA guidance including the detail of a WDA, the Role of the RP, Medicinal products information, Falsified Medicines, QMS, Train the trainer, and other relevant topics. In addition, ensure that initial and continuous training for all personnel involved in distribution activities are implemented and the training system is effective.
Ensure audit of the quality system is completed on a regular basis by periodic review of QMS and operational procedures for regulatory compliance through internal audit system
Ensure that there is a qualified warehouse with a temperature monitoring system available which can provide temperature alerts as required
Ensure there is a qualified warehouse management system available for use to ensure product traceability and enable FEFO
Assist in the development and review of validation documentation for systems at the facility as required
Ensure there is a system in place to handle returned, rejected or recalled product
Ensure that procedures are in place for receipt of products, replenishment, pick and pack and dispatch, quarantine, release, reject, return, recall and disposal of product and other critical operations
Ensure that the operations do not compromise the quality of medicines by ensuring that the systems are in place to monitor storage of the product at the premises and during transport in cases where the company is responsible for transport
Ensure procedures are in place for management of audits and inspections and the issues identified are acted upon in a timely manner
Where contract organizations are used, responsible for review and approval of the Quality Agreements/Service Level Agreements and ensuring that contractors are qualified and performing as required by the agreement.
Ensure Quality agreements with clients are in place and clearly define all responsibilities in relation to GDP. Provide clients with reports in relation to Quality KPls as required in relation to their activities.
Ensure that clients and their suppliers to site are legitimate and hold the appropriate licences. In addition, dependant on Quality Agreements, ensure customers are approved in compliance with the GDP requirements.ie bona-fides.
Essential Requirements:
Third level qualification in Science, Engineering, Applied Maths or equivalent
Relevant experience in a similar role in a fast paced, high tech manufacturing environment
Computer Literate
Proficient in SPC & Statistics
Green Belt certified
Knowledge and experience of Lean/ Six Sigma practices and principles
Knowledge of ISO 13485
Knowledge of GDP & HPRA Requirements Behavioural Competencies
Experience in supply chains
Knowledge experience in Project Management
Experience in Lean/6 Sigma.
SAP Knowledge
Validation experience
If you are interested in the above role, please apply to job reference KR/571 on www.recruitmentbureau.com.
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