Quality Assurance Specialist - Fixed-Term

About the role

GE HealthCare's Oslo factory in Storo produces sterile and aseptic contrast media. Its Quality Assurance organization covers quality assurance of systems, processes, facilities and projects, as well as product release, and is split into QA Systems and Documentation and Batch Release. The company is looking for a motivated, quality-focused Quality Assurance Specialist to strengthen the QA Systems team. The role focuses on quality and regulatory compliance in sterile and aseptic pharmaceutical manufacturing, with particular responsibility for SAP-related processes and approval of artwork and packaging materials, and drives continuous improvement through a LEAN approach. It is a temporary position of one year.

Key responsibilities

• Ensure compliance with GMP requirements and quality standards in sterile and aseptic pharmaceutical manufacturing.
• Perform quality-related assessments and approvals in SAP, including material master data, specifications, product structures and change processes.
• Approve artwork, labels, packaging materials and associated changes in line with regulatory requirements and product specifications.
• Provide quality assurance support to manufacturing, laboratories and support functions.
• Analyse quality data and trends to identify improvement opportunities and strengthen the quality management system.
• Prepare, revise and approve procedures, work instructions and other GMP documentation.
• Take part in internal and external audits and regulatory inspections and follow up observations.
• Support training and coaching in GMP, aseptic behaviour, data integrity and quality processes.
• Participate in deviation handling, quality investigations, CAPA and change control as needed.

Required profile

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, Engineering or a related scientific discipline.
• Experience in the pharmaceutical industry, preferably in sterile or aseptic manufacturing.
• Fluent Norwegian and English, written and spoken.
• Preferred: experience with deviation management, CAPA, change control, LEAN, operational excellence, risk management and auditing in regulated environments.

Required skills

• Strong knowledge of GMP, including EU GMP and Annex 1.
• Experience with SAP and quality processes such as master data and material management.
• Experience approving artwork, labels or packaging materials.
• Good analytical skills and structured problem-solving approach.