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 (Eudra Lex 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