Reporting to the Quality Defects and Recall Manager, the Scientific Officer works within the Quality Defects & Recall Programme of the Market Compliance section. The role includes performing risk-based technical evaluations and assessments of suspected and confirmed Quality Defect reports on medicines. The Scientific Officer reviews and/or recommends actions which are designed to remediate and correct the non-compliance issue at hand, to ensure patient and animal safety.
The Scientific Officer works closely and maintains effective working relationships with the other members of the Quality Defects & Recall team, as well as with other members of the Market Compliance section and the Compliance department as a whole, to ensure that any required interactions are effectively implemented, and that the objectives of the Quality Defect & Recall programme are met.
The Scientific Officer maintains effective working relationships with colleagues in other sections and departments of this company and with external stakeholder groups, to ensure that Quality Defect & Recall issues requiring cross-functional and external input are effectively investigated and followed up on.
- Strategic Objectives
o Supporting the Quality Defects and Recall Manager in the investigation and risk-based decision-making in relation to Quality Defect reports and in coordinating product recalls and other risk-reducing actions in the marketplace.
o Ensuring that the work objectives of the Quality Defects and Recall programme are met, and that its operational goals are achieved.
o Providing technical support to other colleagues within the Market Compliance section, where required. This may specifically involve assisting in Advertising Compliance work in relation to medicinal product advertising.
o Promoting a positive, open, friendly and professional working environment.
o Assisting in the compilation of data and preparation of monthly, annual and other Quality Defect & Recall reports, as required.
o Maintaining appropriate records of meetings and activities.
o Attending and contributing to meetings of the Market Compliance section.
- Technical Objectives
o Conduct Quality Defect investigations & co-ordinate product recalls and other risk-mitigating actions in line with relevant procedures, policies, and guidance, including Quality Risk Management principles.
o Apply analytical and problem-solving skills to quality defect issues.
o Assist with the logging in, tracking and up-keep of Quality Defect & Recall case files, to ensure that the files are logged according to defined procedures, are up-to-date and contain all of the relevant documentation relating to that Quality Defect & Recall issue.
o Review, from a technical aspect, the data in the Quality Defect & Recall databases (as inputted by Market Compliance Administrative staff), and ensure that the databases are up-to-date and contain accurate information.
o Assist in maintaining the Quality Defect & Recall databases as required.
o Assist in implementing communications strategies for Quality Defect & Recall issues.
o Generate and issue Rapid Alert and Safety Alerts, and other such alerts, when requested.
o Participate in Market Compliance-related inspections, as needed.
o Attend meetings which relate to Quality Defect and Recall issues, as needed.
o Work to promote and carry out the development and improvement of all aspects of the Quality Defect & Recall Programme.
- Quality and Knowledge Management
o Work to ensure the effective implementation of Quality Management System within the Quality Defect & Recall Programme. Assist in work to ensure that there are effective mechanisms in place to capture, store and communicate key information, experience and knowledge gained by the Quality Defect & Recall Programme.
o Work to ensure that available information and knowledge is effectively used by the Quality Defect & Recall Programme.
o Work to ensure that Quality Defect & Recall Programme remains up to date with relevant developments in national, European and International regulations, legislation and guidelines.
- Performance Management
o Participate in the performance management programme (PDP) within the Market Compliance section to maximise efficiency gains for the department.
o Work to promote effective performance within the Market Compliance section.
o Promote the taking of measures to identify and resolve issues impacting performance in the Quality Defect & Recall Programme.
o Report regularly on progress against specified goals/targets and objectives.
- Communication/Customer Service
o Working to help develop and implement a communication strategy for the Quality Defect & Recall Programme.
o Working to help develop education and/or communication programmes with stakeholders for the Quality Defect & Recall Programme.
o Liaising with officers of the State, other bodies, and industry sections, as appropriate, on Quality Defect & Recall issues.
- Team Development
o Work to ensure the provision of training to colleagues of the Market Compliance section and Compliance department, when requested.
o Participate in technical and skills training and continuous professional development.
o Participate in induction and ongoing training, including comprehensive on the job training.
o Attend technical quality system training.
o Observe GMP and GDP inspections, when required.
QUALIFICATIONS AND EXPERIENCE
- To be considered for this post, candidates must have:
o 3rd level degree in a relevant scientific or related discipline
o Relevant experience in research, healthcare, industry or regulatory environment
o Possess the requisite knowledge and ability, suitability and administrative capacity for proper discharge of the duties of the office
o Proven ability to work unsupervised
o Highly motivated and with the ability to manage deadlines
o Demonstrated initiative and team working capabilities
o Excellent computer skills
o Proven ability to work effectively as part of a multi-disciplinary team
o Excellent communication skills with the proven ability to deliver appropriate information to the right people using a range of written, verbal and presentation skills
o Proven ability to work with others in a collaborative and solutions focused manner
- In addition the following would be considered an advantage:
o Post graduate qualification in a relevant scientific or related discipline
o Exposure to complaint investigations, root cause analysis and CAPA (Corrective Action and Preventative Action) related work
o A working knowledge of the EU GMP requirements, particularly those elements relating to Pharmaceutical Quality Systems and Complaint investigations.
o Relevant experience in the collation, evaluation and presentation of scientific data
o Experience in the development or implementation of quality management systems
If you would like further Information you can contact the recruiter directly:
Libby Ryan | Tel: +353 (0) 1 507 9254