Qualified Person
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| Job Type | Permanent |
| Area | Sligo |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3002 |
| Job Views | 1136 |
- Description
- Team Horizon is seeking a QP on behalf of our client, who are a globally recognized pharmaceutical company. This role is a permanent position, based at their state-of-the-art biologics manufacturing facility.
Why you should apply:
Join a company whose goal is to help patients live healthier lives and are proud to be a Great Place to Work.
Be part of a diverse and dynamic team where you will have the opportunity to work with experienced leader in a globally recognised biotech company.
What you will be doing:
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.
What you need to apply:
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
2 Years’ experience gained within an aseptic processing environment, ideally gained within a quality function.
Experienced Qualified Person (minimum 1 years’ experience acting as a QP) required.
