Job ID: JOB-12739
CAPA Specialist (Operations Technical Specialist)
Our Client, A globally leading Medical Device Multi-national are currently seeking a CAPA Specialist to join their team on a permanent basis in Longford. Commutable from Westmeath, Roscommon, Cavan & Leitrim, the successful candidate will be tasked with supporting the site non-conformance process through developing and maintaining the Global QMS.
- Develop Subject Matter Expertise, and take lead, in designated CAPA/process/technical specialty.
- Train / mentor fellow team members, including peers, as required.
- Establish oneself as key contact for designated process.
- Develop and maintain working relationship with cross-functional peers, including Technical Support, Quality and Supply Chain.
- Provide necessary support to production schedule requirements as designated by Team Leader.
- Champion the principles and practices of GMP/GLP and 5 Pillars. Lead by example, and provide mentoring support for team members.
- Minimise generation of deviations by ensuring that all relevant documentation is being followed.
- Demonstrate an understanding of the application of the Quality Policy through daily activities.
- Ensure effective communication of process information and manufacturing issues to Team Leader.
- To ensure that the plant meets the quality requirements of its customers, internal quality systems, internal & external auditors and other external agencies.
- To liaise with, seek appropriate advice from and report when necessary to colleagues in Sligo, Lake County, Dartford and Wiesbaden.
- To participate in the Self-Assessment procedure per site procedures.
- To assist in the periodic review of controlled documents per site procedures.
- Maintain ETMS To Do List.
- Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well as the Global & Technical Standards.
- You will have a third level qualification in a relevant Chemistry or Life Science discipline
- Relevant professional qualification as this level of education provides a necessary foundation for this Job function.
- A minimum of 20 months experience in a regulated environment of which 12 months is in the manufacturing/testing or support of diagnostic products.
- A relevant post-graduate qualification with 12 months experience in the manufacturing/testing or support of diagnostic products.
- A relevant professional qualification, together with a minimum of 12 months experience of supporting the manufacture/test of diagnostic products.
For further information on this role in please contact Mark Wilson on 0860449473 or email firstname.lastname@example.org
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