Senior QA Specialist: GMP Compliance & Release

Curium Live Forward; Newcastle upon Tyne; On-site; GBP 55,000 - 75,000; Full time

Job summary

Curium Live Forward is seeking a QA professional to ensure GMP compliance across production and analytical operations in line with EU GMP and current pharmaceutical guidelines. You will support a culture of excellence at the site and contribute to continuous improvement within the Quality Management System.

The role involves managing deviations, CAPA, change controls, batch review for QP release, and maintaining QC data integrity. Strong communication and analytical skills are essential.

Qualifications

• Degree in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology.
• 2 years Quality Systems experience.
• Experience in GMP facilities.
• Sound knowledge of general management practices.

Responsibilities

• Review production and analytical method compliance with GMP/specials guidelines and EP/BP/SmPC.
• Manage documentation including review/update of SOPs and forms.
• Assist with deviations, incidents, investigations, OOS, CAPA, Change control and release of incoming materials.
• Review QC tests and Micro results, manage Out of Specification results.
• Ensure timely completion of Quality records and trackers.
• Assist with inspection readiness and regulatory responses.
• Oversee validation report reviews for equipment per VMP.

Skills

Radiation knowledge

Strategic thinking

Technical aptitude

Communication skills

Stress management

Interpersonal skills

Education

Degree in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology

Job description

Curium Live Forward is seeking a QA professional to ensure GMP compliance across production and analytical operations in line with EU GMP and current pharmaceutical guidelines. You will support a culture of excellence at the site and contribute to continuous improvement within the Quality Management System.

The role involves managing deviations, CAPA, change controls, batch review for QP release, and maintaining QC data integrity. Strong communication and analytical skills are essential.