• Posted date 27 November 2022
• LocationDublin
• Job type Permanent

• Salary€ 85000
• Discipline Life Sciences
• ReferenceJO-2211-505404

Qualified Person

Dublin North

Pharmaceutical

Onsite

CPL recruitment are once again delighted to support our key client in to source a QP for this pharmaceutical site in Dublin north. For this hire they are looking for a QP that has been on license for at least 3 years and that has the ability and desire to mentor other more junior QP’s as they develop their careers.

• To act as a QP in the Batch Release group
• Certify medicinal product in accordance with requirements of product marketing authorization, EU Directive 2001/83/EC & 2001/20/EC 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.
• Leading a small team of Qualified Persons.
• 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 QA Manager
• Participating in company projects to assist with optimising Quality compliance

The successful applicant will possess the following knowledge, skills, qualifications and experience.

• Experience working as a QP on a manufacturing license for at least 3 years.
• Experience working within a pharmaceutical manufacturing environment in a Quality capacity (QA or QC).
• BSc Degree in related discipline along with MSc or Post grad which leads to QP status
• Experience of Quality systems to include but not limited to deviation, out of specs, risk management.
• Previous experience in a Pharma Solid Dosage environment would be beneficial

For a confidential discussion, please reach out to Aisling.murray@cpl.ie