Description
Role – Qualified PersonType – 6 month contract
Location – Co. Cork Ireland
Key Responsibilities:
The above position will be working with the Quality department within the Sterile team, carry the following responsibilities:
- Execute the responsibilities of a Qualified Person as per Annex 16
- Perform the QP Release of both commercial and clinical Finished Products manufactured on site,
- Lead and participate as a team member in Quality Continuous Improvement projects
- Provide QP Guidance to the site
- Participate in Investigations / Fact Finding Meetings as required and drive CAPA effectiveness.
- Ensure compliance with cGMP and other business compliance regulations and Procedures.
- Participation in Corporate/Regulatory Inspections on site when required.
- Training and development of area personnel
- Delivery of area performance to meet or exceed performance or quality goals.
- Active participation at the Deviation Review Board, Stability Review Board, Site Quality Council and other relevant forums pertinent to product quality review.
- Lead, promote and participate in the implementation and maintenance of the SHE programmes where relevant.
Key Requirements:
- Third Level science qualification, and a QP Qualification
- Experience working in a Pharmaceutical Environment, preferably in a Sterile Manufacturing Facility.
- Experience of preparing for and participating in regulatory audits in particular IMB/FDA.