Our client, a leading pharmaceutical company located in Mayo is recruiting for a QC Manager. This role, the QC Manager will hold responsibility for all QC activities in support of all aspects of commercial, clinical and development activities at the Mayo site. This is an exciting role to ensure that QC support is provided across all business units and supporting functions as deemed necessary. The successful candidate will provide the necessary guidance relating to QA/QC activities in relation to incoming inspection and release on packaging and manufacturing components.
- The Manager is responsible for the strategy, planning and management of all incoming inspections and releases and resolving component queries, failed inspections of new and in situ components in the QC department.
- Responsible for the coordination and scheduling of QC 2nd shift, night shift and Weekend work, including the resolution of weekend issues, organizing QC Weekend holiday cover and coordinating a meeting with the weekend personnel when they are on a week day shift. The QC Manager coordinates the weekend activities and schedules during normal 2nd shift working hours.
- The QC Manager must show the competence to drive the site forward in terms of quality, compliance and efficiency. This will require both technical, organisational and people management skills and a passion to ensure that the QC department becomes and is maintained as a centre of excellence.
- The QC Manager is expected to be an expert in all aspects related to the work undertaken by the QC department with regards to incoming inspection, release, retention, blocked stock, quarantined stock and file issuance.
- The QC Manager is expected to be aware and knowledgeable of the regulations and the best practices in industry that apply to the QC function and ensure these are implemented as they carry out the day to day activities in the department.
- Aim to work to meet company goals and objectives, customer requirements and the regulatory obligations as laid down by the FDA, EU and regional Ministries of Health.
- Provide required support to the Regulatory Compliance management team for activities associated with the preparation for site audits and inspections.
- Ensure the QC areas and equipment in all buildings are in good repair.
Education, Experience and Skills
- Proven track record in a quality discipline in the Pharma/Medical Device environment.
- Third level Science qualification or equivalent experience in a Pharmaceutical Industry.
- Clear understanding of working within a regulated environment
- Excellent communication skills
- Ability to use sound judgment to make effective decisions within appropriate timeframes
- Proven to be self-directed, self-motivated and ability to prioritise competing priorities
For further information on this QC Manager role in Mayo please contact Caroline Kingston on 0868395531/ email@example.com
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