We are looking for a Senior QA Consultant with strong experience in Quality Assurance and Quality Management within a GMP-regulated laboratory environment. The consultant will ensure compliance, support laboratory operations, and drive quality improvements across testing, documentation, investigations, and validation activities.

Key Responsibilities

• Ensure QA of chemical, physical, and microbiological testing.

• Provide QA support for raw materials, products, and manufacturing processes.

• Review and approve test methods, laboratory documentation, and processes.

• Lead and support deviation investigations, CAPA, and continuous improvement activities.

• Support laboratory validation, qualification, and maintenance.

• Own and manage laboratory-related quality systems.

• Ensure compliance with GMP and established quality systems.

• Participate in Quality Review Boards and cross-functional quality activities.

Requirements

• Proven experience in Quality Assurance within a regulated laboratory environment.

• Strong knowledge of GMP and Quality Management Systems.

• Experience reviewing/approving laboratory documentation and test methods.

• Hands-on experience with laboratory investigations, deviations, and CAPA.

• Experience in validation is highly desirable.

• Background from Pharma, Biotech, Life Science, Medical Device, or GMP-regulated QC laboratories.

• Fluent Swedish and English.

Preferred Experience

• Leadership experience or participation in a Quality Review Board.

• Microbiological expertise.

• QA experience related to raw materials and manufacturing processes.

• Experience driving continuous improvement initiatives.