Quality Systems Specialist


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

10th June 2020

Location

Dublin

Salary/Rate

£36144 - £40662

Type

Permanent

Start Date

ASAP

This job has now expired please search on the home page to find live IT Jobs.

Duties: Quality Assurance:Ensure that the business operates in accordance with European GMP/GDP regulations for drug products, food products, the Medical Device Directive/Regulations and ISO regulations for medical devices and any other relevant guidelines related to the business.Preparation and updating of company SOPs.Providing Administrative support to electronic eQMS system and training to new users as required.Assisting with the preparation of Technical Agreements with all relevant suppliers.Maintaining and coordinating systems relating to QA, including change control, deviations, CAPA, complaints, audits and vendor approval.Generation and reporting of Quality metrics.Logging product complaints follow up with suppliers on investigations in conjunction with the Manufacturing Specialist and close investigations within agreed time frames.Assisting with the preparation of the Quality Management Reviews and Product Quality Review.Performing QA checks on documentation prior to release of products for sale.Projects & Auditing: Leading and supporting projects from QA perspective including product launches into new territories and for new product introductions as required.Provide QA support on MDR Regulation Transition Project.Scoping and implementing new Artwork Management System.Coordinate internal audits, carry-out internal audits and ensure the review, monitoring, reporting of the inspections.Ensuring audit action items are closed within agreed time frame.Assisting with audits and checks on suppliers and ensure the review, monitoring and reporting of the audits.Assisting with preparation for Health/ Competent Authority and Notified Body inspections and prepare regulatory inspection responses.What You Need: 3rd level qualification in a science discipline.5 years minimum of experience in the pharmaceutical and/or medical device industries.Specific experience working in a quality systems or quality assurance role is a requirement for this position.User experience of electronic Quality Management Systems (system administrator would be an advantage).Strong background in the application of GMP/GDP and ISO 13485 standards.Project Management knowledge and practical experience.*Please Note: Sponsorship is not provided for this role. Applicants are required to hold Stamp 4 Visa/Full EU working rights prior to application.* To find out more about Real please visit www.realstaffing.comReal 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

You are currently using an outdated browser.

Please consider using a modern browser such as one listed below: