Senior QA Specialist — Radiopharma & GMP Compliance

Hyper Recruitment Solutions LTD; Newcastle upon Tyne; Presencial; GBP 35.000 - 55.000; Jornada completa

Descripción de la vacante

Hyper Recruitment Solutions Ltd is seeking a Quality Assurance Specialist to support site compliance with GMP, EU GMP, and Specials guidelines within a pharmaceutical environment. The role involves QA/QAQC collaboration across manufacturing and regulatory activities to ensure high-quality radiopharmaceutical products and patient care.

Ideal candidates hold a degree in pharmacy or chemistry and have proven Quality Systems experience in GMP facilities; knowledge of radiopharmaceutical environments

Formación

• Degree or higher in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology.
• Proven experience within Quality Systems and GMP-regulated facilities.
• Knowledge of radiation and radiopharmaceutical environments advantageous, beneficial for role.

Responsabilidades

• Maintain site compliance with GMP, Specials guidelines, applicable pharmacopoeial standards and EU GMP requirements.
• Review production and analytical methods, SOPs, batch records and QC documentation for accuracy and data integrity.
• Assist with deviations, incidents, investigations, OOS results, CAPAs, change controls and regulatory queries.
• Support validation activities, batch reviews, incoming material release and inspection readiness.
• Assist Quality Control activities including environmental monitoring and out-of-spec reporting/investigations.

Conocimientos

Quality Systems

GMP knowledge

Regulatory knowledge

Communication skills

Educación

Degree or higher in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology

Descripción del empleo

Hyper Recruitment Solutions Ltd is seeking a Quality Assurance Specialist to support site compliance with GMP, EU GMP, and Specials guidelines within a pharmaceutical environment. The role involves QA/QAQC collaboration across manufacturing and regulatory activities to ensure high-quality radiopharmaceutical products and patient care.

Ideal candidates hold a degree in pharmacy or chemistry and have proven Quality Systems experience in GMP facilities; knowledge of radiopharmaceutical environments