Role: Contract Role - 3 / 4 days a week
Length: Initial 9 month contract with possibility to extend
Location: West Dublin
To act as a Qualified Person (QP) under the direction of the Head of Quality (QP), performing batch manufacturing records review and EU QP release and associated activities with responsibility for the clients products in accordance with their marketing authorisations ( national or European), their manufacturing authorisations and the principles of GMP in line with Directive 2001/83/C as amended by Directive 2004/27/EC and described in Annex 16 of the EU Guide to GMP.
Key Responsibilities include:
- To certify that batches of finished product have been manufactured and checked in accordance with the Marketing Authorisation, the Manufacturing Authorisation, GMP and legal requirements as set out in Directive 2001/83/C as amended by Directive 2004/27/EC and described in Annex 16 of the EU Guide to GMP
- To ensure that the legal requirements regarding imported products have been met
- To investigate any quality related deviations and support execution of corrective and preventative actions and related documents to ensure compliance is achieved and maintained
- To be present during regulatory inspections, if required
- Bachelor's degree in chemistry, biology or a related discipline
- Quality experience in aseptic or sterile processing
- Eligible to practice as a Qualified Person.
If you are interested in this role, please apply below for immediate consideration. If you would like to know more please feel free to give me a call.
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