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

• 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