|Role Type||Fixed Term Contract|
Job ID: JOB-11476
Qualified Person – QP
My client a North West based Biopharma company with sites around the world is now recruiting for a Qualified Person to join the team in Sligo on a 1 year fixed term contract basis.
A high-potent commercialization and launch facility for small molecule API and Oral Solid Dose products. It is a young and vibrant site that is a strategic product launch facility within the wider Operations network.
As the new Qualified Person (QP), you will be responsible for the disposition of bulk product manufactured at the site, ensuring it is acceptable for release or to be rejected based on the information available relating to the manufacture and testing of the product.
- Ensure products and batches comply with the provisions of the marketing authorisation and per Good Manufacturing Practice
- Certify that the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records
- Ensure that any deviations or planned changes in production or quality control have been authorised by the persons responsible for a defined system
- Verify that any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority
- Confirm that all necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned change
- To 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
- Account for any other factors which are relevant to the quality of the batch
- Maintain and develop knowledge of technical and scientific progress and changes in quality management relevant to the products they are required to certify
- Actively participate in developing relevant and technical knowledge for new products etc.
Education and Experience
- Third level Honours Degree in a science discipline with 5 years’ experience in the healthcare/pharmaceutical industry
- MSc in Industrial Pharmaceutical Science or a similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC.
- 5 years of industrial experience gained in an FDA and EMEA approved pharmaceutical environment
- Strong interpersonal and decision making
For further information on this role please contact Clara Burke on 086 816 8273/ email@example.com
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