Ref No: AM17277
Co. Dublin, Ireland
Quality Engineer - West Dublin.
In this role you will have responsibility for compliance with the quality and regulatory requirements for combination medicinal and device products. This role is also responsible for overseeing the compiling and submitting of technical and quality documents to the relevant authorities in support of obtaining and maintaining the required medicinal product manufacturing authorisations.
• This role will be responsible for the upgrading and maintaining quality systems to meet the requirements of the European and US Medicinal Product and medical device requirement. This includes the establishment, maintenance and continuous improvement of quality systems, procedures and policies.
• Keeping well-informed on regulatory updates, interpreting regulatory drafts or submissions to understand impact, and lead updates as required. The responsibility shall also extend to the advice on compliance risk issues and driving improvement actions. Remain aware of developments in the quality field by reading current quality / regulatory literature and attending relevant meetings and workshops. Monitor local Regulatory Environment and feed back to relevant stakeholders
• Liaise with Customers and regulatory agencies.
• Management of customer documents into the Quality system i.e. Drawings; Purchase Specification; Quality Agreements etc. and the training of relevant personnel.
• Maintain a comprehensive audit readiness program to ensure internal and external compliance for Medicinal Product lines and associated processes
• Develop reports / presentations on the status of the compliance program for senior management team and colleagues.
• Support the Medicinal Product transfer and validation process and/or assembly lines from a customer or company site through QMS set-up to meet specification, and ensuring an agile and compliant operational system.
• Compile and review all relevant batch manufacturing and test data, including deviations and out of specification investigations, for final approval by the QP
• Liaise with the QP on performance of the QMS and emerging quality trends and risks in order to drive quality improvements.
• Adherence to incoming control requirements and supporting the SCAR process when required.
• Lead Customer Complaint investigation to enhance preventive action and reduction of risk to customers and to QMS.
• Facilitate and lead risk assessments to ensure compliance and enhance QMS
• Conduct various Medicinal Product trend analyses to identify short and long range patterns so that recommendations can be made in order to effect continuous improvement necessary to satisfy customer requirements and drive improvements of QMS
Interested applicants should have:
• Minimum requirement is a degree programme in either pharmacy, chemistry, biology, microbiology or equivalent, with at least 5 years' experience in a Medical Device / Pharmaceutical environment, including practical experience of working within a highly regulated quality management system (QMS).
• Knowledge of and experience of maintaining a QMS which meets the legislative requirement of human medicines and medical devices in the EU and USA and the ISO13485 standard.
• Have experience in the facilitation of quality risk management, coupled with a good working knowledge of ISO14971
• Experience of hosting regulatory audits from either the European or US authorities.
• Accredited lead auditor against recognised quality standards in support of internal and supplier audits
• Must be able to organise and prioritise tasks, must be detail orientated and self-motivated.
• Must have excellent written and verbal communication skills.