Quality Assurance Professional

4 days ago

Dublin, Dublin City, Ireland beBeeCompliance Full time €55,000 - €65,000
Job Description

We are seeking a highly skilled Quality Assurance Professional to ensure the maintenance of our client's Quality Management System (QMS) and compliance to ISO 9001 and Good Manufacturing Practice (GMP) requirements.

  • The successful candidate will be responsible for maintaining the internal QMS by raising non-conformances, change controls, Corrective Action Preventative Actions (CAPAs), quality complaints etc. as required.
  • They will also manage the supplier management system, including completion of supplier evaluations, assessments and repeat evaluations according to internal procedures.
  • A key responsibility will be ensuring continual improvement and maintenance of internal Key Performance Indicators (KPIs).
  • Liaising with fellow team members and ensuring awareness to changes to QMS as appropriate will also be an essential part of this role.
Responsibilities Specific to Role of Responsible Person
  • The appointed person will ensure compliance with EU GDP guidelines and other relevant guidelines, including HPRA local guidelines.
  • Experience working under MHRA GDP requirements is advantageous.
  • Ensuring the safety, quality and traceability of products are maintained through the entire supply chain is crucial.
  • All medicinal products wholesaled must be received, stored, transported and delivered under strict GDP conditions.
  • Verifying the bona fides of suppliers/customers/service providers in a timely manner is essential.
Key Requirements
  • A Bachelor's degree in a Life Science subject is required.
  • At least 5 years of Quality and GDP expertise, including previous experience named as an RP on a Wholesale Distribution Authorization (WDA) in Ireland is necessary.
  • Minimum of 5 years experience in Quality and GDP is required.
  • A minimum of one year experience named as an RP on a wholesale distribution authorization in Ireland is required.

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