Senior QA Specialist – GMP Radiopharmaceuticals

Hyper Recruitment Solutions Ltd; North East; On-site; GBP 35,000 - 55,000; Full time

Job summary

Hyper Recruitment Solutions Ltd is recruiting a Quality Assurance Specialist to support GMP compliance, QA/ QC, and regulatory readiness across radiopharmaceutical production. The role involves ensuring data integrity, maintaining quality documentation, and contributing to inspections.

The successful candidate will have a degree in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology, with experience in quality systems and EU GMP knowledge.

Qualifications

• Experience with quality systems within GMP-regulated facilities.
• Strong communication and interpersonal skills under pressure.
• Knowledge of radiation/radiopharmaceutical environments is an advantage.
• Strategic and technically minded with ability to manage priorities.

Responsibilities

• Maintain site compliance with GMP, Specials guidelines and pharmacopoeial standards.
• Review methods, SOPs, forms, batch records and QC data for accuracy and data integrity.
• Assist with deviations, incidents, investigations, CAPAs, change controls and regulatory responses.
• Support validation activities, batch review, material release and inspection readiness.

Skills

Quality Systems

GMP

EU GMP

Data Integrity

Regulatory Inspections

Education

Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology

Job description

Hyper Recruitment Solutions Ltd is recruiting a Quality Assurance Specialist to support GMP compliance, QA/ QC, and regulatory readiness across radiopharmaceutical production. The role involves ensuring data integrity, maintaining quality documentation, and contributing to inspections.

The successful candidate will have a degree in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology, with experience in quality systems and EU GMP knowledge.