Description
Qualified Person - Bio-pharmaceuticalsType - initially 7-8 months
Location - Ireland, South West
One of our global Pharmaceutical leaders are looking for a Qualified Person to join their team to work in the Bio-pharmaceutical sterile manufacturing facility.
The above position will be working with the Quality Department within the Sterile team and have 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.
The successful candidate should possess:
A relevant Third Level science qualification, a QP Qualification and will have relevant experience in a Pharmaceutical Environment, preferably in a Sterile Manufacturing Facility. Leadership skills
Technical knowledge
Ability to respond to changing priorities
Problem solving skills
Communication skills