Qualified Person (QP)

Our client, an established pharmaceutical manufacturing company based in the Munster region, is seeking an experienced Qualified Person (QP) to join its Quality team.

The successful candidate will be responsible for the certification and release of medicinal product batches in accordance with applicable regulatory requirements, Good Manufacturing Practice (GMP), relevant Marketing Authorisations and the site's quality systems.

This is a senior quality position requiring strong knowledge of GMP manufacturing, batch certification and pharmaceutical quality systems.

Responsibilities include but are not limited to

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• Perform Qualified Person certification of finished product batches in accordance with applicable regulatory and GMP requirements.
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• Ensure that batches have been manufactured, tested and controlled in accordance with relevant regulatory requirements, Marketing Authorisations and approved procedures.
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• Review batch manufacturing, packaging, testing and associated quality documentation prior to certification.
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• Ensure appropriate investigation and resolution of deviations, out-of-specification results and other quality events that may impact batch certification.
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• Review and provide appropriate QP input into deviations, CAPAs, change controls and investigations.
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• Support the effective operation and continued development of the site's Pharmaceutical Quality System.
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• Provide quality and compliance guidance in relation to manufacturing, testing, packaging and release activities.
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• Support regulatory inspections and internal and external audits as required.
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• Work closely with Quality Assurance, Quality Control, Manufacturing and other functions to maintain ongoing GMP compliance.
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• Support continuous improvement of quality systems, procedures and compliance processes.
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• Ensure appropriate documentation and records relating to batch certification and release are maintained.
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• Remain current with applicable GMP requirements, regulatory guidance and legislation relating to medicinal product manufacture and certification.