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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Quality Assurance Specialist/Manager


Reference:A015435 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Executive, QA Manager, QA Specialist, QA Supervisor, Quality Manager, Quality Specialist

Quality Assurance Specialist/Manager
Our client, a pharmaceutical organisation, are currently recruiting for a Quality Specialist/Manager to join their team on a permanent basis. As Quality Assurance Specialist/Manager you will play a key role in ensuring compliance with Good Distribution Practice (GDP) requirements and supporting quality activities across the organisation and its affiliates. You will work closely with cross-functional teams including Regulatory Affairs, Pharmacovigilance, Medical Affairs, and Supply Chain, as well as with external partners and regulatory authorities. This is a permanent role with hybrid working.

Responsibilities

  • Support and maintain the Pharmaceutical Quality System (PQS)
  • Assist with quality documentation (Quality Manual, policies, SOPs)
  • Support quality training systems and records
  • Participate in internal and external audits (GDP; GMP desirable)
  • Support quality activities including deviations, CAPAs, change controls, complaints, recalls, and incidents
  • Contribute to Quality Management Reviews through data collection and reporting
  • Maintain technical product files
  • Provide day-to-day QA support and act as quality contact when required
  • Support artwork approval processes
  • Already be a qualified Responsible Person (RP) or demonstrate interest in developing toward a Responsible Person (RP) role

Requirements
  • Scientific degree (pharmacy degree strongly preferred)
  • Minimum 4 years’ experience in a QA or related role within the pharmaceutical sector
  • Strong knowledge of GDP regulations for medicinal products
  • Experience with GDP audits (hosting and performing)
  • Knowledge of GMP (EudraLex Volume 4)
  • GMP audit experience
  • Familiarity with Microsoft 365
  • Self-motivated, organised, and able to work independently
  • Strong communication and collaboration skills
  • Comfortable working in a fast-paced environment
For more information, please contact Sinéad Cullen on +353879500821 or [email protected]