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Senior quality assurance specialist

Tullamore
beBee Careers
Quality assurance specialist
Posted: 16 June
Offer description

Quality Manager Role Summary

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We are seeking a Quality Manager to oversee the Quality Management System, contribute to upholding and improving our organisation's quality standards through collaboration and a focus on compliance.

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Main Responsibilities:

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* Manage site quality documentation, CAPA plans, deviations, change control, and ensure compliance through audits and risk assessments.
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* Collaborate with the production department on quality matters and oversee final batch approval (delegated to QC).
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* Lead process validations, change management activities, and manage measuring instruments.
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* Conduct internal and supplier audits, support third-party audits (customers/notified bodies), and drive related action plans.
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* Monitor and analyse KPIs, prepare reports, lead improvement projects, and deliver training across departments.
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Requirements:

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We are looking for a candidate with minimum 3 years of work experience, preferably in the pharmaceutical or graphic industry, with a strong background in Quality Assurance within a GMP-regulated environment.

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A good knowledge of ISO 9001, GMP pharmaceutical requirements, risk analysis, and familiarity with ISO 19011 is essential. Experience with Lean Manufacturing, 8D reporting, or project management is a plus.

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Proficient in Microsoft Office (Word, Excel, Outlook) and experience with ERP systems are required.

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Demonstrated ability to work with precision and a continuous improvement approach within quality systems is necessary.

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Desirable Skills:

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* Lean Manufacturing
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* ISO 19011
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* Project Management
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About Us

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We value your trust and confidentiality. We will only contact you about this job opportunity and will not share your data with any clients without your consent.

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Please note that due to the expected high volume of applications, we can only reply to applicants suitable for the position.

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