Are you interested in working for a QA team who is creative, passionate, collaborative and determined to succeed?
My key client in Dublin City Centre offers prospective employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement.
As the QA Specialist you will be responsible supporting the Director of Quality in ensuring regulatory compliance for all medicinal products distributed by QA/RP function and supporting through proactive monitoring, the quality performance of contract manufacturers, distributors and material suppliers to applicable GMP/GDP standards. Additionally GMDP Quality Contractor is responsible for supporting the Director of Quality in ensuring implementation of Quality Management systems and monitoring the operation of the systems.
Role: QA Specialist
Contract: 6 month Daily rate contract
Location: Dublin City Centre
As the QA Specialist your Essential Duties and Responsibilities are:
- Ensure the effective use of the quality management system of the MAH and WDA holder
- Support the quality efforts with regard to new market launches
- Support in the preparation of the EU site for upcoming regulatory inspections from a WDA, MIA, MAH or PV perspective.
- Support Product Complaints and Recall process for EU & OUS.
- Support the qualification of new vendors and Contract Service Providers for EU and OUS.
- Work with US counterparts to lead and monitoring the daily operations at Contract Manufacturer(s) and distributors, as relevant
- Provide support to resolution of open investigations, deviations, CAPAs and change controls together with the Director of Quality/RP and QP in order to ensure timely release of supplies to market.
- Documentation and investigating product complaints, deviations, change controls, and supporting product related investigations.
- Supporting product and distribution related investigations and supporting product quality related priorities and tasks at the respective contract manufacturers, distributors and/or suppliers.
- Minimum of a Bachelor's Degree in Science or a healthcare related field and a minimum of 2-3 year's relevant practical and managerial experience of medicinal products is required.
This is a great opportunity to join a truly global community in Dublin City Centre. Not sure yet? No CV ready? Give me a call on 01-8883477 for more information!
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 Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales