Description:
We are looking for QA Compliance Specialist at at our Ballytivnan Sligo site, This will a 12 month contact position.
The person will be responsible for the disposition of bulk product manufactured at site as acceptable for release or reject based on the information available relating to the manufacture and testing of the product.
To disposition bulk product as acceptable for release, or reject, to ensure patient safety based on the information available relating to the manufacture and testing of the batch
Key Responsibilities:
- 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.
- Should in addition take into account any other factors of which they are aware which are relevant to the quality of the batch.
- Should maintain their knowledge and experience up to date in the light of technical and scientific progress and changes in quality management relevant to the products they are required to certify.
- Ensure that they have gained the relevant knowledge and experience to certify a batch of a product type with which they are unfamiliar, for example because a new product range has been introduced, prior to certification.
Qualifications
- Third level qualification in a science discipline with 5 years' experience in the pharmaceutical industry.
- Desirable: 2 Years’ experience gained within an aseptic processing environment, ideally gained within a quality function.