Senior Quality Assurance Officer
- United Kingdom
- Permanent
- Full-time
- Support the GxP Quality Management System by conducting audits, managing deviations, and ensuring compliance with EU GMP and GDP standards.
- Manage supplier assurance processes, including external audits, technical agreements, and quality improvement plans.
- Oversee product release to the market, ensuring regulatory compliance and reviewing batch release documentation.
- Act as a Responsible Person (RP) and Responsible Person for Import (RPi), ensuring GDP compliance and addressing non-conformities.
- Conduct risk assessments, implement corrective and preventive actions (CAPA), and deliver training on GDP and regulatory compliance.
- Collaborate with supply chain, logistics, and warehousing teams to ensure efficiency and compliance without compromising product quality.
- Maintain accurate records, respond to regulatory inspections, and ensure continuous professional development (CPD)
- A degree in chemistry or a related life sciences field, with membership in a professional body (e.g., Royal Society of Chemistry/Biology/Pharmacy).
- Significant QA experience in an EU GMP and GDP-regulated environment, with knowledge of quality management systems and sterile product manufacturing.
- Proven experience as a Responsible Person (RP) or RPi on a named license, with expertise in GDP and GMP auditing.
- Strong decision-making, problem-solving, and risk management skills to address significant non-compliances.
- High attention to detail, excellent communication skills, and the ability to work effectively in a fast-paced regulatory environment.
- Solid understanding of EU regulations and guidance related to GMP and GDP, with experience advising on CAPA, deviations, and change controls.