Quality Assurance Specialist/Manager
Our client, a pharmaceutical organisation, is currently recruiting for a Quality Specialist/Manager to join their team on a permanent basis.
As a 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 **************** or ******
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