CAPA Specialist (Operations Technical Specialist)
Job ID: JOB-12923
Working in Corrective Action & Preventative Action is in big demand right now. We’re looking to speak with experienced CAPA Specialist’s (Operations Technical Specialist) who are looking to work with top global leaders who value their people. This is a great job opportunity in Longford for a CAPA Specialist (Operations Technical Specialist) who enjoys working on innovative projects, values autonomy in their job and working in a great team. Talk with us about this newly created CAPA Specialist (Operations Technical Specialist) job opportunity in Longford to find out more. We currently have an open position for a CAPA Specialist and this role involves the following:
- Support the site non-conformance process through developing and maintaining expertise the GQMS (Global Quality Management System) process and by facilitating the timely generation and completion of non-conformance and potential non-conformance reports.
- To ensure the plant meets its customer quality, service, regulatory, financial and safety goals through effective technical support of Diagnostic products.
- To provide the necessary support to the site non-conformance process in the centralised CAPA group, ensuring that timeliness targets at site and divisional level are met for all open CAPA items, and to ensure a high standard of technical writing is employed in the building of non-conformance / potential non-conformance reports.
- To facilitate cross functional meetings associated with non-conformances / potential non-conformances and to populate the GQMS system with inputs provided by area owners.
- 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 cross functionally and dual site.
- To participate in the site AIDD 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 company standards.
Supervisory / Management Responsibility
- Works independently or as an individual contributor.
Education & Experience
- You will have one of the following: o A third level qualification in a relevant Chemistry or Life Science discipline. o Relevant professional qualification as this level of education provides a necessary foundation for this Job function.
- You will also have one of the following: o A minimum of 20 months experience in a regulated environment of which 12 months is in the manufacturing/testing or support of diagnostic products. o Relevant post-graduate qualification with 12 months experience in the manufacturing/testing or support of diagnostic products. o A relevant professional qualification, together with a minimum of 12 months experience of supporting the manufacture/test of diagnostic products.
- Excellent communication and presentation skills.
- Advanced organisational skills and attention to detail.
- The ability to work co-operatively and effectively with others to establish and maintain good working relationships.
- A proven self-starter with the highest level of integrity in the successful completion of your work.
- Excellent time keeping, attendance and performance record are a pre-requisite for this role.
For further information on this role in Sligo please contact Cliona Lawton on Hireme@hero.ie or 086-8168298
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
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