Qualified Person
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| Job Type | Fixed Term |
| Area | Sligo, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #1001984 |
| Job Views | 69 |
- Description
- We are recruiting for role to join our client’s team on a 1-year fixed contract basis. 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.
Why you should apply:
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.
Excellent career progression opportunities.
What you will be doing:
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.
What you need to apply:
Third level qualification 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
