QA Specialist & Qualified Person
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| Job Type | Permanent |
| Area | Sligo, Ireland |
| Sector | QualityOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2334 |
| Job Views | 106 |
- Description
- Are you an experienced Quality Specialist with QP experience? If the answer is yes, Team Horizon havean exciting opening at our client’s state of the art facility for a QA Specialist and QP on a permanent basis at our client’s state of the art Biologics manufacturing facility. Reporting to the Quality Operations Lead, you will ensure that products manufactured meet requirements of end users, Regulatory Authorities, relevant GMPs and the company. You are 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.
Why you should apply:
With an exciting pipeline of products and a great salary and benefits package, this may be the career move you have been waiting for!
Excellent career progression opportunities.
What you will bedoing:
You will ensure the batch and its manufacture comply with the provisions of the marketing authorisation and that manufacture has been carried out in accordance with Good Manufacturing Practice.
You will ensure the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records and 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.
As QA/QP Specialist, you will 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.
Support all audits and their completion as required by the quality assurance system.
What you need to apply:
A third level qualification in a science discipline with 5 years' experience in the pharmaceutical industry
MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
2 Years’ experience gained within an aseptic processing environment, ideally gained within a quality function is preferred
