Qualified Person required for multinational pharma company based in Cork. This comapny combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases.
As the QP you will contribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations and to act as Qualified Person for the site.
QP Responsibilities will include:
o Release of Finished and Semi-Finished Products
o Acting as Qualified Person in compliance with the regulatory and legal requirements of this title.
o Assisting in the completion of Annual Product Review (data collection, graphic analysis…)
o Participating to the review and updating of the regulatory filing (US & European, DMF type 1…), with the collaboration of the regulatory department.
o Completing quality assurance review of batch documentation as required:
o Making sure that critical deviations are investigated and resolved
o Reviewing and assessment of GMP critical systems
o Participating and follow-up the audits and/or inspections carried out at the site by the authorities or clients, propose corrective actions and check that they are applied..
o Qualified Person Qualification as defined in EU GMP volume 4 and annex 16.
o At least 2 years experience as a QP on manufacturing license
o Previous management / supervisory experience an advantage
o Experience of GMP auditing and documentation.
o Ability to critically assess issues and execute problem solving
Please contact Kathy on 021 4777329 for full details of this role or apply directly through this advert.