Quality Specialist

3 weeks ago

Dublin, Dublin City, Ireland Clinigen Full time

We are looking to expand our Quality team based in our Dublin Warehouse

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.

We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC, and South Africa. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.

To support our growth, we are seeking a confident and proactive Quality Specialist to join us, working directly with the Quality Manager to support the business in relation to all Quality matters outlined below.

Requirements
  • Follow, promote, and enforce relevant SOPs, Job Aids, and Company policies and procedures.
  • Assist in ensuring that the appropriate standards of GMP and GDP are maintained.
  • Originate, review, approve, maintain, and archive quality documentation, including policies, SOPs, etc.
  • Assist in organizing and delivering appropriate training in this area.
  • Coordinate Quality Assurance raw data to ensure compliance with regulatory expectations.
  • Collate raw data to support monthly quality system indicator (QMS) reporting.
  • Contribute to the delivery of QA projects as required.
  • Promptly deal with QA enquiries with due diligence.
  • Ensure all quality-critical documents are properly prepared, maintained, reviewed, filed, and archived to meet regulatory and customer expectations, providing reports to the group head of Quality, Quality Manager, and other nominated parties.
  • Coordinate QA raw data, including Change Controls, CAPA Management, Deviation Investigations, Temperature Excursion Investigations, Product Discrepancy Investigations, Product Recalls, and Quality Complaints.
  • Manage the QA inbox.
  • Support the self-inspection process.
  • Support the Supplier Approvals Process.
Benefits
  • 27 days holiday plus 8 bank holidays.
  • Life assurance of 3x annual salary.
  • Annual salary review.
  • Independent financial advice service.
  • Long service awards.
  • Recognition scheme & employee of the year awards.
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