QA compliance specialist
Posted on Feb 1, 2021 by Real Staffing Group
My client, a leading Pharmaceuticals company based in the West of Ireland, is looking for a QA compliance specialist to join their growing quality department, what you will have the opportunity to work on a new biologics expansion project, where they are currently moving into manufacturing support.
Not only will you be working on a site with exceptional culture, recognised for being a fantastic work environment, but you will be joining at a stage where the Quality team is growing, bringing increased opportunities within the company.
This is an initial 6 month hourly rate contract, and as the QA compliance specialist, you will be responsible for the following:
- Ensure the batch and its manufacture comply with the provisions of the marketing authorisation.
- Ensure manufacture has been carried out in accordance with Good Manufacturing Practice.
- Ensure the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records.
- Ensure any deviations or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority.
- Ensure all the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes.
- Ensure all necessary production and quality control documentation has been completed and endorsed by the staff authorised to do so.
- Ensure all audits have been carried out as required by the quality assurance system.
- Third level qualification in a science discipline with minimum 3 years' experience in the pharmaceuticals industry.
- 3 years industrial experience gained in an FDA and EMEA approved pharmaceutical environment.
- Desirable: 2 Years' experience gained within an aseptic processing environment, ideally gained within a quality function.
Please note we are currently only considering applications form candidates currently based in the Republic of Ireland.
If you are interested in this role and would like to learn more, please respond to this advert and I will give you a call to discuss in detail.
Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales