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Role: Quality Compliance Manager Location: Dublin Industry: Medical Devices Contract - 12 month fixed term contract Other conditions: Remote working flexibility
Reporting to the Quality Manager this role will be responsible for the upgrading and maintaining of 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. You will manage and work closely with the quality compliance team and perform the following duties in this role:
* Provide regulatory guidance to the business including regulatory training, keeping well-informed on regulatory updates, interpreting regulatory drafts or submissions to understand impact to West CM (Dublin) 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 * Develop, lead and maintain a comprehensive audit readiness program to ensure internal and external compliance * Develop reports / presentations on the status of the compliance program for senior management team and the wider organisation network. * Embed QMS management principles in the organisation & drive continuous improvement * Liaise with the QP on performance of the QMS and emerging quality trends and risks. * Conduct various 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 * Work closely with the NPI and Operations Department to ensure that programs are introduced in a manner that complies with the appropriate regulatory requirements, customer specification and consistent with the(QMS) * Lead continuous improvement initiatives to 'challenge' the quality systems processes with respect to compliance / value add. * Act in accordance with the company's Guiding Principles and adherence to the corporate Code of Conduct. * Compliance to all site Environmental, Health and Safety requirements, training and regulations.
Requirements: * Minimum requirement is a degree programme in either pharmacy, chemistry, biology, microbiology or equivalent with at least 5 years in a Medical Device / Pharmaceutical environment, including practical experience of working within a highly regulated quality management system (QMS). * Knowledge of and experience in setting up and 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
To be considered for this role please apply with an up-to-date CV.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales