In partnership with our expanding multinational Pharma client, we are now recruiting an experienced Qualified Person to join the team on a 1-year fixed contract basis. As our new Qualified Person (QP), you will be responsible for the management of multiple site projects include batch size increase, optimization of the current commercial process, assurance of supply initiatives, whilst driving quality and project plan related discussions to closure by working with all relevant functional teams and effectively troubleshooting and driving decisions.
With an exciting pipeline of products and a great salary and benefits package, this may be the career move you have been waiting for.....
Duties and Responsibilities:
Support and implement key site strategies/initiatives (batch size increase, optimization of current commercial process, assurance of supply initiatives) on time and within budget
Manage multiple projects concurrently, operating with minimal supervision
Proactively identify and drive quality and project plan related issues to closure by working with all relevant functional lines and effectively troubleshooting and driving decisions
Understand project drivers, requirements, scenarios and options. Proactively drive the development of contingency and/or risk mitigation plans.
Manage competing timelines and make difficult decisions regarding priorities among projects.
Effectively communicate and present project status to Operations senior management and stakeholders.
Maintain and develop knowledge of technical and scientific progress and changes in quality management relevant to the products they are required to certify
Actively participate in developing relevant and technical knowledge for new products etc.
Ensure all audits have been carried out as required by the quality assurance system
Ensuring that new products manufactured at AbbVie Ireland NL B.V. meet applicable regulatory requirements and AbbVie procedures and policies.
Ensure products and batches comply with the provisions of the marketing authorisation and per Good Manufacturing Practice, including clinical manufacturing supply.
Ensure that any deviations or planned changes in production or quality control have been authorised by the persons responsible for a defined system.
Confirm that all necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned change.
To ensure all necessary production and quality control documentation has been completed and endorsed by the staff authorised.
Third level qualification in a science discipline with 5 years experience in the healthcare/pharmaceutical industry
MSc in Industrial Pharmaceutical Science or a similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC.
5 years of industrial experience gained in an FDA and EMEA approved pharmaceutical environment
Strong interpersonal and decision making
For a confidential discussion and more information on the role, please contact Rory Walsh.