Qualified Person
West of Ireland – Sligo
Pharmaceutical
Permanent
CPL recruitment are once again delighted to support our key client in to source a QP for this biopharmaceutical site in Sligo. For this hire they are looking someone that has a good solid background in quality and that is keen to get established as a QP. Rare opportunity not to be missed.
You will support the Manager, QA in the day to day running of the QA department, with a particular emphasis on batch disposition and the supervision of related quality systems.
- To act as a QP in the Batch Release group
- Certify medicinal product in accordance with requirements of product marketing authorization, Article 97 Veterinary Medicinal Directive 2019/6, and EU GMP Annex 16.
- Assist in the coordination of the QA operational duties relating to product disposition.
- Participate in investigations and risk assessments related to manufacturing deviations and changes and ensuring appropriate actions are implemented.
- Ensure product release procedures comply with current regulatory and company requirements.
- Coordinating deviation investigations, log trend deviations and issuing regular reports on such trends.
- Acting as a point of contact for Production, Engineering, QC and Technical Affairs GMP issues.
- Advising and providing input into quality systems across the plant.
- Coordinating sampling activities for incoming materials
- Coordinating the release of packaging materials on completion of testing
- Coordinating the on-line inspections of packed product
- QA review of documentation, including SOP’s, worksheets, logbooks.
- Any other related activities as indicated by the Manager, QA
The successful applicant will possess the following knowledge, skills, qualifications and experience.
- Experience working within a pharmaceutical manufacturing environment in a Quality capacity (QA or QC).
- QP qualification
- Experience of Quality systems to include but not limited to deviation, out of specs, risk management.
For a confidential discussion, please reach out to [email protected] or call me on 087 4671309
