QA Specialist - Cork
12 Month Contract.
The QA Specialist will be the key point of contact for all next gen project related activities including liaising with global team and senior site management for the duration of the NextGen roll out project. Once the project is complete and the new system is fully stable you will revert to a QA11 role within the Quality training and system team.
Roles and Responsibilities:
- Lead or support the NextGen project by preforming/coordinating all associated QA related tasks and assigned related tasks as per the project timelines in accordance with site procedures and GMP regulations. Provide QA advice and support as required. Inform QA management of project status, potential quality issues, and significant changes to current site practices.
- May conduct or serve as a lead/coordinator of deviations and CAPA recommendations. Supporting both training and QA systems.
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. These may include the running and design of weekly metrics for training on time deviations, on time CAPA closure and change controls along with other QA metrics.
- This role may be responsible for the weekly delivery of GMP Induction training and may be required to design and deliver annual GMP Refresher training. Also deliver one to one GMP training when business needs arise.
- Exercises judgement within well-defined and established procedures and practices to determine appropriate action - identifies problems and generates alternatives and recommendations within defined processes.
- Participates in developing SOP's to ensure quality objectives are met.
- Act as a mentor to junior staff in the System/Training team and will need to support a number of new staff as they come up to speed.
- Normally receives very little instruction on routine work, general instructions on new assignments.
Education and Experience:
- Degree in appropriate discipline + 2 years' experience.
- GMP experience.
- Diploma in QA with sufficient experience.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.