Doina Culin

Senior Quality Assurance Specialist @HCA Healthcare UK

London, GB

Led and delivered QA services to hospital manufacturing and QC units, ensuring full compliance with MHRA regulations and NHS guidance.Successfully maintained and integrated Quality Systems under ML (Specials) and MA(IMP) licenses, supporting regulatory inspections and audits.Provided expert QA support for Clinical Trials, ensuring adherence to GCP and statutory requirements across multiple trial phases.Acted as Releasing Officer for licensed products, progressing toward nomination as an EU Qualified Person (QP).Managed and resolved QA complaints, liaising with DMRC and MHRA, achieving timely closure and process improvements.Delivered key QA contributions to the Trust’s R&D agenda, driving continuous improvement and reducing operational variation.Oversaw feedback mechanisms for product quality, including complaints, non-conformances, recalls, deviations, and audits.Coordinated and reported on the Trust GMP Internal Audit Programme, ensuring timely follow-up and resolution of findings.Approved SLAs, SOPs, and Technical Agreements for external hospitals, sponsors, and manufacturing units.Provided EQMS training to QC staff, including handling of unusual events and deviation reporting.Reviewed and approved service contracts, technical agreements, and specifications for raw materials, packaging, and finished products.Established and implemented environmental monitoring procedures for pharmacy production areas, with full documentation and trend analysis.

University of Exeter

Postgraduate Degree, Clinical, Hospital, and Managed Care Pharmacy

Royal College of Physicians of Ireland

Diploma of Education, Infectious Disease

Universitatea OVIDIUS din Constanta

Bachelor of Pharmacy - BPharm, Medicinal and Pharmaceutical Chemistry