GMP Quality Assurance Specialist – Audits & Compliance

Catalent; Bathgate; On-site; GBP 32,000 - 48,000; Full time

Benefits offered by this job

Pension scheme matching up to 7.5%

Life assurance

Private medical insurance (BUPA)

Generous holiday entitlement

Training and cross-functional learning

Job summary

Catalent Bathgate, UK seeks a Quality Specialist to support GMP objectives and QA processes, managing GMP documentation and reviewing material specifications to ensure compliance with pharmacopoeia, GMP, and client requirements. The role will collaborate with cross-functional teams to drive continuous improvement.

Onsite at Bathgate, responsibilities include internal audits, TrackWise closure, audit responses, and timely release of materials.

Qualifications

• Bachelor of Science in a relevant scientific topic or equivalent quality experience in a pharmaceutical environment.
• Proven number of quality experience in a Pharmaceutical or Clinical Trials setting.

Responsibilities

• Carry out GMP quality objectives and policies.
• Provide QA expertise to ensure processes meet acceptable standards.
• Manage GMP documentation and track timely flow.
• Review material specifications for compliance with pharmacopoeia, GMP and client requirements.
• Review/approve incoming, intermediate, and finished materials for release.
• Review randomisations, QA documentation, and packaging batch records for accuracy.
• Liaise with cross-functional teams to resolve quality issues and maintain delivery timelines.
• Support Quality Management System activities including TrackWise closure.
• Conduct internal audits, monitor trends, and support continuous improvement.

Skills

Verbal Communication

Written Communication

Attention to Detail

workload prioritisation

Independent Working

Analytical & problem solving

Decisive on quality issues

Environmental Monitoring (Desirable)

Client-facing

Education

Bachelor of Science in a relevant scientific topic

Job description

Catalent Bathgate, UK seeks a Quality Specialist to support GMP objectives and QA processes, managing GMP documentation and reviewing material specifications to ensure compliance with pharmacopoeia, GMP, and client requirements. The role will collaborate with cross-functional teams to drive continuous improvement.

Onsite at Bathgate, responsibilities include internal audits, TrackWise closure, audit responses, and timely release of materials.