QA Senior Specialist

Gi Group UK; Neuenburg; Presencial; CHF 90.000 - 140.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality Assurance

GMP/GDP

External CMOs

Sterile manufacturing

QA documentation

Regulatory audits

English

German desirable

Educación

Bachelor's or Master's in science

Descripción del empleo

About the Role

We are seeking an experienced QA Specialist to support quality oversight activities across external manufacturing partners. The role focuses on ensuring compliance with GMP requirements, maintaining quality systems, and managing quality events related to commercial pharmaceutical products.

Key Responsibilities

• Oversee quality activities at external manufacturing and testing partners.
• Review and approve deviations, investigations, change controls, complaints, and validation documentation.
• Support batch release activities and product disposition decisions.
• Ensure compliance with GMP/GDP requirements and internal quality standards.
• Maintain quality agreements and collaborate closely with contract manufacturers.
• Participate in audits, inspections, and supplier quality management activities.
• Monitor quality metrics, trends, and continuous improvement initiatives.
• Contribute to quality system maintenance, SOP updates, and regulatory inspection readiness.

Required Profile

• Bachelor's or Master's degree in a scientific discipline.
• Minimum 3 years of Quality Assurance experience within the pharmaceutical industry.
• Experience with sterile manufacturing is essential.
• Solid understanding of GMP/GDP regulations and pharmaceutical quality systems.
• Experience managing quality activities with external manufacturers or CMOs.
• Strong analytical, problem-solving, communication, and stakeholder management skills.
• English fluent; German is highly desirable.
• Experience supporting regulatory inspections and audits is advantageous.

Note

Occasional travel may be required.