Quality Assurance Specialist/Manager
Life Science Recruitment View all jobs
- Dublin
- Permanent
- Full-time
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
- 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