Senior QA Specialist – GMP & External Manufacturing Oversight

Gi Group UK; Neuenburg; On-site; CHF 90,000 - 140,000; Full time

Job summary

Gi Group UK is seeking an experienced QA Specialist to support quality oversight activities across external manufacturing partners. The role focuses on GMP/GDP compliance, maintaining quality systems, and managing quality events for commercial pharmaceutical products.

You will oversee QA activities at CMOs, review deviations and validation docs, support batch release decisions, and participate in audits. A Bachelor's or Master's in a science field and at least 3 years in pharma QA with sterile

Qualifications

• Bachelor's or Master's degree in a scientific discipline.
• At least 3 years of QA experience in pharma.
• Experience with sterile manufacturing and GMP/GDP compliance.
• Experience with external manufacturers/CMOs.

Responsibilities

• Oversee QA activities at external manufacturing and testing partners.
• Review deviations, investigations, change controls, complaints, and validation docs.
• Support batch release and product disposition decisions.
• Ensure GMP/GDP compliance and internal quality standards.
• Maintain quality agreements and collaborate with CMOs.
• Participate in audits, inspections, and supplier quality management.
• Monitor quality metrics and drive continuous improvement.
• Support SOP updates and inspection readiness.

Skills

Quality Assurance

GMP/GDP

External CMOs

Sterile manufacturing

QA documentation

Regulatory audits

English

German desirable

Education

Bachelor's or Master's in science

Job description

Gi Group UK is seeking an experienced QA Specialist to support quality oversight activities across external manufacturing partners. The role focuses on GMP/GDP compliance, maintaining quality systems, and managing quality events for commercial pharmaceutical products.

You will oversee QA activities at CMOs, review deviations and validation docs, support batch release decisions, and participate in audits. A Bachelor's or Master's in a science field and at least 3 years in pharma QA with sterile