Manager Quality Control Laboratories(Swedish)

Aurora Engineering AB; Uppsala kommun; On-site; SEK 650,000 - 900,000; Full time

Job summary

Aurora Engineering AB in Sweden seeks a Senior QA Consultant to drive quality assurance and quality management within GMP-regulated laboratory environments, supporting testing, documentation, investigations, and validation activities.

You will lead deviation investigations, CAPA, and continuous improvement while owning laboratory quality systems and ensuring alignment with GMP standards. Fluency in Swedish and English is required.

Qualifications

• Proven experience in QA 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.

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.

Skills

Quality Assurance

GMP

Quality Management

CAPA

Deviation Investigations

Validation

Laboratory Documentation

Swedish

English

Job description

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.