Freelance/Contract Principal Quality Assurance Consultant

About the role

ProPharma, a consultancy advising biotech, medical device and pharmaceutical organisations, is looking for an experienced Quality Assurance Consultant (lead level) to support a client on an urgent project. The contract or freelance role starts immediately, runs full-time for at least 3-4 months and possibly longer, and is best suited to independent consultants able to work largely onsite in the Uppsala region.

Key responsibilities

• Review and support the development of key quality system activities in line with compliance and global regulatory standards
• Support and guide the client on quality remediation needed to complete the project
• Provide key support on investigations and CAPA management
• Review all manufacturing activities from a QA perspective and ensure improvements are implemented
• Contribute to inspection readiness, including compliance assessments and mock audits
• Work closely with senior department heads and subject matter experts

Required profile

• BSc or higher in a life sciences discipline
• Extensive experience in the pharmaceutical or biotechnology sector
• Extensive QA experience at a small-medium enterprise level
• Experience managing complex QA issues and creating solutions
• Fluent English; Swedish desirable
• Ability to work mainly office-based in Uppsala

Required skills

• Thorough knowledge of FDA regulations is highly advantageous
• Problem-solving skills and ability to support corrective procedures
• Understanding of key regulations to ensure compliance