Senior Quality Engineer - North Dublin

ICDS RECRUITMENT

North Dublin

Senior Quality Engineer & Deputy Responsible Person - North Dublin. Main tasks/responsibilities of this role: Quality: • Pro-actively work with all customers to ensure the company is continually meeting and exceeding their requirements. • Keep appraised of all new developments and 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. • Represent the Quality Department for all NPI activity via participation in all NPI meetings. • 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 (Responsible Person): Support RP (Responsible Person) in relation to: • Represent the company in the role of Deputy RP at the time of inspection and ongoing after that time to ensure the conditions of the WDA are met. • 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 Practice are applied to documentation. • Ensure there is a system in place for Complaints (both service and product) and that customer complaints are dealt with in an effective and timely manner. • Ensure there is a system in place for deviations, investigations, root cause analysis and CAPA's, and that such processes are managed in a timely manner. • Ensure that Change Control systems are established and implemented. • In relation to recalls: Ensure there is a robust recall process in place which is tested annually with a mock recall. Support the RP in co-ordination of a prompt recall of medicinal products under instruction of the regulatory agency and relevant clients. • Ensure there is a Falsified Medicines procedure in place to assist in identification of potential Falsified Medicines and management of such product. In addition, to report on such matters to clients and regulatory agencies in a timely manner. • 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 the organisational structure is defined and that clear job descriptions are available for all personnel involved in distribution activities. • 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 as required. • Ensure there is a systems 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 transportin 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. • Ensure there is a procedure in place for Quality Management Review and assist with the preparation of materials for such a process, attend the meeting, ensure minutes and actions are taken and followed up on actions occurs. • Ensure the management of third parties (CMO's and affiliates) including regular review and auditing of their Quality Management Systems either by personnel or through the management of audits contracted to qualified third parties, to ensure compliance with applicable legislation and regulations. • Ensure any subcontracted activities which may impact on GDP are approved and that suppliers and customers are approved. • Ensure the conditions of the WDA are met. Interested applicants should have: ■ 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 literacy. ■ Proficiency in SPC & statistics. ■ Knowledge of ISO 13485. ■ Knowledge of GDP & HPRA Requirements. It would be useful to have: ■ Experience in supply chain. ■ Knowledge or experience in Project Management. ■ Experience in Lean/6 Sigma. ■ SAP Knowledge. ■ Validation experience.

662 days ago